FCC ID QRIPNP

Implantable Pulse Generator

by BIOTRONIK SE & Co. KG

Grantee Code: QRI Product Code: PNP

Latest application date: 2018-11-20

Device Images

FCC ID QRIPNP ID Label Location Info — ID Label Location Info

FCC ID Device Details

FCC ID	QRIPNP
Mirrors	fcc.id \| gov \| fccid.ai
Grantee Code	QRI
Product Code	PNP
Applicant Business	BIOTRONIK SE & Co. KG 🇩🇪
Related Domains	biotronik.com
Equipment Class	Implantable Pulse Generator
Test Firm	Eurofins Product Service GmbH

Operating Frequencies

Frequency Range	Application Purpose	Final Action Date
402.45-404.85 MHz	Class II permissive change or modification of presently authorized equipment	2018-11-20
402.45-404.85 MHz	Class II permissive change or modification of presently authorized equipment	2017-02-15
402.45-404.85 MHz	Original Equipment	2016-04-07

Exhibits

Document	Type	Available	File
15a_UserMan_Enticos	Users Manual	2016-10-04	PDF 1.4 MB
15b_UserMan_Enitra	Users Manual	2016-10-04	PDF 1.3 MB
15c_UserMan_Evity	Users Manual	2016-10-04	PDF 1.3 MB
15d_UserMan_Edora	Users Manual	2016-10-04	PDF 668.7 KB
Int pho	Internal Photos	2019-04-30	PDF 76.8 KB
Ext pho	External Photos	2019-04-30	PDF 166.7 KB
QRIPNP_ExtPho	External Photos	2017-02-15	PDF 290.7 KB
08_PNP ExtPho	External Photos	2016-10-04	PDF 183.9 KB
06_PNP Edora 8 HF-T Label Sample	ID Label/Location Info	2016-04-07	PDF 122 KB
07a_PNP LabelLocStatement_RevB	ID Label/Location Info	2016-04-07	PDF 436.7 KB
17_PNP AntSpec	Operational Description	2016-04-07	PDF 348.2 KB
Test setup pho	Test Setup Photos	2019-04-30	PDF 62.2 KB
10_PNP TSupPho	Test Setup Photos	2016-10-04	PDF 276.5 KB
Test report	Test Report	2018-11-20	PDF 1.2 MB
QRIPNP_TRpt	Test Report	2017-02-15	PDF 2.5 MB
14a_PNP TestRep 95I	Test Report	2016-04-07	PDF 1.7 MB
14c_PNP TestRep 15C exclusion	Test Report	2016-04-07	PDF 699.1 KB
04_PNP AutLet-U	Attestation Statements	2016-04-07	PDF 328.1 KB
C2PC letter	Cover Letter(s)	2018-11-20	PDF 60.7 KB
Con req lt	Cover Letter(s)	2018-11-20	PDF 113.1 KB
Con req st	Cover Letter(s)	2018-11-20	PDF 118.8 KB
Family letter	Cover Letter(s)	2018-11-20	PDF 20.8 KB
PoA	Cover Letter(s)	2018-11-20	PDF 60.2 KB
QRIPNP_Autlet	Cover Letter(s)	2017-02-15	PDF 21.7 KB
QRIPNP_C2PC Letter	Cover Letter(s)	2017-02-15	PDF 21.8 KB
QRIPNP_ConReq	Cover Letter(s)	2017-02-15	PDF 21.6 KB
05_PNP ConReq-U	Cover Letter(s)	2016-04-07	PDF 422.5 KB
24_PNP ShortConReq_RevB	Cover Letter(s)	2016-04-07	PDF 445.4 KB
18_PNP SAR Statement	RF Exposure Info	2016-04-07	PDF 420.8 KB
09_PNP IntPho Metadata only	Internal Photos		PDF 181.1 KB
12_PNP BlkDia Metadata only	Block Diagram		PDF 41.4 KB
13a_PNP Schem Metadata only	Schematics		PDF 103.7 KB
13b_PNP Schem Metadata only	Schematics		PDF 93.7 KB
11_PNP OpDes Metadata only	Operational Description		PDF 129.4 KB
Antenna spec Metadata only	Operational Description		PDF 60.8 KB
QRIPNP_AntSpec Metadata only	Operational Description		PDF 22.3 KB
16a_PNP 0232(2260-03) PartsLst Metadata only	Parts List/Tune Up Info		PDF 38.6 KB
16b_PNP 0234(2260-03) PartsLst Metadata only	Parts List/Tune Up Info		PDF 38.6 KB
16c_PNP 0227(2270-04) PartsLst Metadata only	Parts List/Tune Up Info		PDF 43.2 KB

Application Information

Application ID	FFcCojC4ijIAdCBMeZuL2g==
Final Action Date	2018-11-20
Application Purpose	Class II permissive change or modification of presently authorized equipment
Applicant FRN	0008008591
Model	PNP
Frequency Range	402.45-404.85 MHz
Equipment Class	TNT - Licensed Non-Broadcast Transmitter Worn on Body
Device Description	Implantable Pulse Generator
Responsible Party	Gunnar Boersch, Team Manager Regulatory Affairs, gunnar.boersch@biotronik.com , +49-30-68905-0
Test Firm	Jorg Kusig, Eurofins Product Service GmbH, joergkusig@eurofins.de , 49-33631-888-700
TCB Email	JoergKusig@eurofins.de
TCB Scope	B2: General Mobile Radio And Broadcast Services equipment in the following 47 CFR Parts 22 (non-cellular) 73, 74, 90, 95, 97, & 101 (all below 3 GHz)
Short-Term Confidentiality	Yes
Short-Term Confidentiality Date	04/30/2019
Long-Term Confidentiality	Yes
Grant Deferral	No
Modular Equipment	Does not apply
Composite Device	No
Composite Part	No
Cognitive Radio	No
Authorization Waiver	No
Authorization Waiver Approved	No
Section 5301 Certification	Yes
Related OET Knowledge DataBase Inquiry	No
Grant Comments	Output power is E.I.R.P.

Applications

Application ID	Date	Purpose
FFcCojC4ijIAdCBMeZuL2g==	2018-11-20	Class II permissive change or modification of presently authorized equipment
smUB1FIJxw24IvDwZpfUKg==	2017-02-15	Class II permissive change or modification of presently authorized equipment
rum5OnPgIhExRSoSlT4WtQ==	2016-04-07	Original Equipment

Equipment Authorization

Frequency	Output	Tolerance	Emission	Rules	Grant Notes
402.45-404.85 MHz	0.0000003	5.9000000000ppm	230KF1D	95I	IT

Grants

TCB Grant - Application smUB1FIJxw24IvDwZpfUKg==

TCB	GRANT OF EQUIPMENT AUTHORIZATION	TCB
Certification
Issued Under the Authority of the
Federal Communications Commission
By:

Eurofins Product Service GmbH
Storkower Strasse 38c
D-15526 Reichenwalde,
Germany

Date of Grant: 02/15/2017

Application Dated: 02/15/2017

BIOTRONIK SE & Co. KG

Woermannkehre 1

P.O. Box 470255,

Berlin, 12359
Germany

Attention: Gunnar Boersch , Team Manager Regulatory Affairs

NOT TRANSFERABLE

EQUIPMENT AUTHORIZATION is hereby issued to the named GRANTEE, and is VALID ONLY for the equipment identified hereon for use under the Commission's Rules and Regulations listed below.

FCC IDENTIFIER:	QRIPNP

Name of Grantee:	BIOTRONIK SE & Co. KG

Equipment Class:	Licensed Non-Broadcast Transmitter Worn on Body
Notes:	Medical Implant Pacemaker

Grant Notes	FCC Rule Parts	Frequency Range (MHZ)	Output Watts	Frequency Tolerance	Emission Designator
IT	95I	402.45 - 404.85	3E-7	5.9 PM	230KF1D

Output power is E.I.R.P.

IT:	Implanted Transmitter

EAS Grant - Application smUB1FIJxw24IvDwZpfUKg==

COPY	FEDERAL COMMUNICATIONS COMMISSION WASHINGTON, D.C. 20554 GRANT OF EQUIPMENT AUTHORIZATION	COPY
Certification

BIOTRONIK SE & Co. KG
Woermannkehre 1 P.O. Box 470255,
Berlin, 12359
Germany

Date of Grant: 02/15/2017

Application Dated: 02/15/2017

Attention: Gunnar Boersch , Team Manager Regulatory Affairs

NOT TRANSFERABLE

EQUIPMENT AUTHORIZATION is hereby issued to the named GRANTEE, and is VALID ONLY for the equipment identified hereon for use under the Commission's Rules and Regulations listed below.

FCC IDENTIFIER:	QRIPNP

Name of Grantee:	BIOTRONIK SE & Co. KG

Equipment Class:	Licensed Non-Broadcast Transmitter Worn on Body
Notes:	Medical Implant Pacemaker
Modular Type:	Does not apply

Grant Notes	FCC Rule Parts	Frequency Range (MHZ)	Output Watts	Frequency Tolerance	Emission Designator
IT	95I	402.45 - 404.85	3E-7	5.9 PM	230KF1D

Output power is E.I.R.P.

IT:	Implanted Transmitter

TCB Grant - Application rum5OnPgIhExRSoSlT4WtQ==

Mail To:

TCB	GRANT OF EQUIPMENT AUTHORIZATION	TCB
Certification
Issued Under the Authority of the
Federal Communications Commission
By:

Eurofins Product Service GmbH
Storkower Strasse 38c
D-15526 Reichenwalde,
Germany

Date of Grant: 04/07/2016

Application Dated: 04/07/2016

BIOTRONIK SE & Co. KG

Woermannkehre 1

P.O. Box 470255,

Berlin, 12359
Germany

Attention: Gunnar Boersch , Team Manager Regulatory Affairs

NOT TRANSFERABLE

EQUIPMENT AUTHORIZATION is hereby issued to the named GRANTEE, and is VALID ONLY for the equipment identified hereon for use under the Commission's Rules and Regulations listed below.

FCC IDENTIFIER:	QRIPNP

Name of Grantee:	BIOTRONIK SE & Co. KG

Equipment Class:	Licensed Non-Broadcast Transmitter Worn on Body
Notes:	Medical Implant Pacemaker

Grant Notes	FCC Rule Parts	Frequency Range (MHZ)	Output Watts	Frequency Tolerance	Emission Designator
IT	95I	402.45 - 404.85	3E-7	5.9 PM	230KF1D

Output power is E.I.R.P

IT:	Implanted Transmitter

EAS Grant - Application rum5OnPgIhExRSoSlT4WtQ==

COPY	FEDERAL COMMUNICATIONS COMMISSION WASHINGTON, D.C. 20554 GRANT OF EQUIPMENT AUTHORIZATION	COPY
Certification

BIOTRONIK SE & Co. KG
Woermannkehre 1 P.O. Box 470255,
Berlin, 12359
Germany

Date of Grant: 04/07/2016

Application Dated: 04/07/2016

Attention: Gunnar Boersch , Team Manager Regulatory Affairs

NOT TRANSFERABLE

EQUIPMENT AUTHORIZATION is hereby issued to the named GRANTEE, and is VALID ONLY for the equipment identified hereon for use under the Commission's Rules and Regulations listed below.

FCC IDENTIFIER:	QRIPNP

Name of Grantee:	BIOTRONIK SE & Co. KG

Equipment Class:	Licensed Non-Broadcast Transmitter Worn on Body
Notes:	Medical Implant Pacemaker
Modular Type:	Does not apply

Grant Notes	FCC Rule Parts	Frequency Range (MHZ)	Output Watts	Frequency Tolerance	Emission Designator
IT	95I	402.45 - 404.85	3E-7	5.9 PM	230KF1D

Output power is E.I.R.P

IT:	Implanted Transmitter

TCB Grant - Application FFcCojC4ijIAdCBMeZuL2g==

Mail To:

TCB	GRANT OF EQUIPMENT AUTHORIZATION	TCB
Certification
Issued Under the Authority of the
Federal Communications Commission
By:

Eurofins Product Service GmbH
Storkower Strasse 38c
D-15526 Reichenwalde,
Germany

Date of Grant: 11/20/2018

Application Dated: 11/20/2018

BIOTRONIK SE & Co. KG

Woermannkehre 1

P.O. Box 470255,

Berlin, 12359
Germany

Attention: Gunnar Boersch , Team Manager Regulatory Affairs

NOT TRANSFERABLE

EQUIPMENT AUTHORIZATION is hereby issued to the named GRANTEE, and is VALID ONLY for the equipment identified hereon for use under the Commission's Rules and Regulations listed below.

FCC IDENTIFIER:	QRIPNP

Name of Grantee:	BIOTRONIK SE & Co. KG

Equipment Class:	Licensed Non-Broadcast Transmitter Worn on Body
Notes:	Implantable Pulse Generator

Grant Notes	FCC Rule Parts	Frequency Range (MHZ)	Output Watts	Frequency Tolerance	Emission Designator
IT	95I	402.45 - 404.85	3E-7	5.9 PM	230KF1D

Output power is E.I.R.P.

IT:	Implanted Transmitter

EAS Grant - Application FFcCojC4ijIAdCBMeZuL2g==

COPY	FEDERAL COMMUNICATIONS COMMISSION WASHINGTON, D.C. 20554 GRANT OF EQUIPMENT AUTHORIZATION	COPY
Certification

BIOTRONIK SE & Co. KG
Woermannkehre 1 P.O. Box 470255,
Berlin, 12359
Germany

Date of Grant: 11/20/2018

Application Dated: 11/20/2018

Attention: Gunnar Boersch , Team Manager Regulatory Affairs

NOT TRANSFERABLE

EQUIPMENT AUTHORIZATION is hereby issued to the named GRANTEE, and is VALID ONLY for the equipment identified hereon for use under the Commission's Rules and Regulations listed below.

FCC IDENTIFIER:	QRIPNP

Name of Grantee:	BIOTRONIK SE & Co. KG

Equipment Class:	Licensed Non-Broadcast Transmitter Worn on Body
Notes:	Implantable Pulse Generator
Modular Type:	Does not apply

Grant Notes	FCC Rule Parts	Frequency Range (MHZ)	Output Watts	Frequency Tolerance	Emission Designator
IT	95I	402.45 - 404.85	3E-7	5.9 PM	230KF1D

Output power is E.I.R.P.

IT:	Implanted Transmitter

Mail To: