FCC ID QRITACHNT2

Implantable Cardioverter Defibrillator

by BIOTRONIK SE & Co. KG

Grantee Code: QRI   Product Code: TACHNT2
Latest application date: 2017-01-24

Device Images

FCC ID Device Details

FCC IDQRITACHNT2
Mirrorsfcc.id | gov | fccid.ai
Grantee CodeQRI
Product CodeTACHNT2
Applicant BusinessBIOTRONIK SE & Co. KG 🇩🇪
Related Domains biotronik.com
Equipment ClassImplantable Cardioverter Defibrillator
Test FirmEurofins Product Service GmbH

Operating Frequencies

Frequency RangeApplication PurposeFinal Action Date
402.45-404.85 MHzClass II permissive change or modification of presently authorized equipment2017-01-24
402.45-404.85 MHzOriginal Equipment2016-04-11

Exhibits

DocumentTypeAvailableFile
15a_[TACHNT2] UserMan_InlexaUsers Manual2016-10-08PDF 1.4 MB
15b_[TACHNT2] UserMan_IliviaUsers Manual2016-10-08PDF 2.6 MB
15c_[TACHNT2] UserMan_InticaUsers Manual2016-10-08PDF 2.6 MB
09_[TACHNT2] IntPhoInternal Photos2016-10-08PDF 1.5 MB
08_[TACHNT2] ExtPhoExternal Photos2016-10-08PDF 2.8 MB
06_[TACHNT2] LabelSmpID Label/Location Info2016-04-11PDF 99.9 KB
07_[TACHNT2] LabelLoc_Statement_Rev.BID Label/Location Info2016-04-11PDF 429 KB
17_TACHNT2 CL2PCH modific AntSpecOperational Description2017-01-24PDF 22.4 KB
17_[TACHNT2] AntSpecOperational Description2016-04-11PDF 261.3 KB
10_[TACHNT2] TSupTest Setup Photos2016-10-08PDF 431.6 KB
14a_TACHNT2 TestRep 15CTest Report2017-01-24PDF 2.8 MB
14b_TACHNT2 TestRep 95MIRTest Report2017-01-24PDF 3.1 MB
14a_ [TACHNT2]TestRep TNTTest Report2016-04-11PDF 1.5 MB
14b_[TACHNT2] TestRepTest Report2016-04-11PDF 992 KB
04_TACHNT2 CL2PCH modific AutLetAttestation Statements2017-01-24PDF 21.8 KB
04_[TACHNT2] AutLet-UAttestation Statements2016-04-11PDF 258.6 KB
05_TACHNT2 CL2PCH modific ConReqCover Letter(s)2017-01-24PDF 21.6 KB
30_TACHNT2 CL2PCH modific Cl2PChLetterCover Letter(s)2017-01-24PDF 21.8 KB
05_[TACHNT2] ConReq-UCover Letter(s)2016-04-11PDF 334.7 KB
24_[TACHNT2] ShortConReqCover Letter(s)2016-04-11PDF 362.1 KB
18_[TACHNT2] SARRF Exposure Info2016-04-11PDF 382.5 KB
12_[TACHNT2] BlkDia Metadata onlyBlock DiagramPDF 107.7 KB
13_TACHNT2_Schem Metadata onlySchematicsPDF 200 KB
11_[TACHNT2] OpDes_Cor_MB Metadata onlyOperational DescriptionPDF 41.8 KB
16_TACHNT2_PartsLst_RevB Metadata onlyParts List/Tune Up InfoPDF 113.3 KB
16_[TACHNT2] PartsLst Metadata onlyParts List/Tune Up InfoPDF 96.9 KB

Application Information

Application IDx91+odm9yhZMN2sKw17XKg==
Final Action Date2017-01-24
Application PurposeClass II permissive change or modification of presently authorized equipment
Applicant FRN0008008591
ModelTACHNT2
Frequency Range402.45-404.85 MHz
Equipment ClassTNT - Licensed Non-Broadcast Transmitter Worn on Body
Device DescriptionImplantable Cardioverter Defibrillator
Responsible PartyGunnar Boersch, Team Manager Regulatory Affairs, gunnar.boersch@biotronik.com , +49-30-68905-0
Technical ContactDirk Koenig, Biotronik SE & Co.KG, dirk.koenig@biotronik.com , 00493068905
Test FirmJorg Kusig, Eurofins Product Service GmbH, joergkusig@eurofins.de , 49-33631-888-700
TCB Emailjoergkusig@eurofins.de
TCB ScopeB2: 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 ConfidentialityNo
Long-Term ConfidentialityYes
Grant DeferralNo
Modular EquipmentDoes not apply
Composite DeviceNo
Composite PartNo
Cognitive RadioNo
Authorization WaiverNo
Authorization Waiver ApprovedNo
Section 5301 CertificationYes
Related OET Knowledge DataBase InquiryNo
Grant CommentsOutput Power is EIRP

Applications

Application IDDatePurpose
x91+odm9yhZMN2sKw17XKg==2017-01-24Class II permissive change or modification of presently authorized equipment
4XsAdixq9FCcjvfC+XLcvQ==2016-04-11Original Equipment

Equipment Authorization

FrequencyOutputToleranceEmissionRulesGrant Notes
402.45-404.85 MHz0.00000204.0000000000ppm235KF1D95IIT

Grants

TCB Grant - Application x91+odm9yhZMN2sKw17XKg==

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: 01/24/2017

Application Dated: 01/24/2017
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:  QRITACHNT2
Name of Grantee:  BIOTRONIK SE & Co. KG
Equipment Class: Licensed Non-Broadcast Transmitter Worn on Body
Notes: Implantable Cardioverter Defibrillator
Grant Notes  FCC Rule Parts Frequency
Range (MHZ)
Output
Watts
Frequency
Tolerance
Emission
Designator
IT 95I 402.45  -  404.85 0.000002 4.0  PM 235KF1D

Output Power is EIRP

IT: Implanted Transmitter

EAS Grant - Application x91+odm9yhZMN2sKw17XKg==

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: 01/24/2017

Application Dated: 01/24/2017
 
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:  QRITACHNT2
Name of Grantee:  BIOTRONIK SE & Co. KG
Equipment Class: Licensed Non-Broadcast Transmitter Worn on Body
Notes: Implantable Cardioverter Defibrillator
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 0.000002 4.0  PM 235KF1D

Output Power is EIRP


IT: Implanted Transmitter

TCB Grant - Application 4XsAdixq9FCcjvfC+XLcvQ==

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: 04/11/2016

Application Dated: 04/11/2016
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:  QRITACHNT2
Name of Grantee:  BIOTRONIK SE & Co. KG
Equipment Class: Licensed Non-Broadcast Transmitter Worn on Body
Notes: Implantable Cardioverter Defibrillator
Grant Notes  FCC Rule Parts Frequency
Range (MHZ)
Output
Watts
Frequency
Tolerance
Emission
Designator
IT 95I 402.45  -  404.85 0.000002 4.0  PM 235KF1D

Output Power is EIRP

IT: Implanted Transmitter

EAS Grant - Application 4XsAdixq9FCcjvfC+XLcvQ==

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: 04/11/2016

Application Dated: 04/11/2016
 
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:  QRITACHNT2
Name of Grantee:  BIOTRONIK SE & Co. KG
Equipment Class: Licensed Non-Broadcast Transmitter Worn on Body
Notes: Implantable Cardioverter Defibrillator
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 0.000002 4.0  PM 235KF1D

Output Power is EIRP


IT: Implanted Transmitter

Mail To: