1. FCC ID
  2. QRI
  3. QRIPRIMUS

FCC ID QRIPRIMUS

PRIMUS (aka EVIA or ENTOVIS) family of implantable pacemakers

by BIOTRONIK SE & Co. KG

Grantee Code: QRI   Product Code: PRIMUS
Latest application date: 2010-03-09

FCC ID Device Details

FCC IDQRIPRIMUS
Mirrorsfcc.id | gov | fccid.ai
Grantee CodeQRI
Product CodePRIMUS
Applicant BusinessBIOTRONIK SE & Co. KG 🇩🇪
Related Domains biotronik.com biotronikusa.com
Equipment ClassPRIMUS (aka EVIA or ENTOVIS) family of implantable pacemakers
Test FirmEurofins Product Service GmbH

Operating Frequencies

Frequency RangeApplication PurposeFinal Action Date
402-405 MHzOriginal Equipment2010-03-09

Exhibits

DocumentTypeAvailableFile
QRIPRIMUS UserManUsers Manual2010-03-09PDF 2.7 MB
R3 QRIPRIMUS UserManUsers Manual2010-03-09PDF 800.8 KB
QRIPRIMUS ExtPhoExternal Photos2010-03-09PDF 284.3 KB
QRIPRIMUS LabelLocID Label/Location Info2010-03-09PDF 652.1 KB
QRIPRIMUS LabelSmplID Label/Location Info2010-03-09PDF 459.5 KB
R1 2 QRIPRIMUS LabelLocID Label/Location Info2010-03-09PDF 28.4 KB
QRIPRIMUS TSupTest Setup Photos2010-03-09PDF 139.9 KB
QRIPRIMUS TestRpt 95ITest Report2010-03-09PDF 1.8 MB
R6 7 8 QRIPRIMUS TRpt revTest Report2010-03-09PDF 2.2 MB
ItembyItemResponseCover Letter(s)2010-03-09PDF 93.6 KB
QRIPRIMUS AutLetCover Letter(s)2010-03-09PDF 612.7 KB
QRIPRIMUS ConReqCover Letter(s)2010-03-09PDF 2.5 MB
QRIPRIMUS Form 731 TNTCover Letter(s)2010-03-09PDF 1.8 MB
QRIPRIMUS RFExp - MPERF Exposure Info2010-03-09PDF 445.8 KB
R9 QRIPRIMUS SAR analysisRF Exposure Info2010-03-09PDF 446.2 KB
RF ExposureRF Exposure Info2010-03-09PDF 447.2 KB
RFEXp SAR AnalysisRF Exposure Info2010-03-09PDF 464.9 KB

Application Information

Application IDAy8xkBa9E2z81ZQfRuO6ZA==
Final Action Date2010-03-09
Application PurposeOriginal Equipment
Applicant FRN0008008591
ModelPRIMUS
Frequency Range402-405 MHz
Equipment ClassTNT - Licensed Non-Broadcast Transmitter Worn on Body
Device DescriptionPRIMUS (aka EVIA or ENTOVIS) family of implantable pacemakers
Responsible PartyGunnar Boersch, Team Manager Regulatory Affairs, gunnar.boersch@biotronik.com , +49-30-68905-0
Technical ContactPaul Stadnik, Micro Systems Engineering, Inc., paul.stadnik@biotronik.com , +1 503 635-4016
Non-Technical ContactJim Horton, Biotronik USA, Inc., jim.horton@biotronikusa.com , +1 503 635-4016
Test FirmJorg Kusig, Eurofins Product Service GmbH, joergkusig@eurofins.de , 49-33631-888-700
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
Ay8xkBa9E2z81ZQfRuO6ZA==2010-03-09Original Equipment

Equipment Authorization

FrequencyOutputToleranceEmissionRulesGrant Notes
402-405 MHz0.00000021.9500000000ppm182KF1D95IIT

Grants

TCB Grant - Application Ay8xkBa9E2z81ZQfRuO6ZA==

This application does not exist.

EAS Grant - Application Ay8xkBa9E2z81ZQfRuO6ZA==

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: 03/09/2010

Application Dated: 12/10/2009
 
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:  QRIPRIMUS
Name of Grantee:  BIOTRONIK SE & Co. KG
Equipment Class: Licensed Non-Broadcast Transmitter Worn on Body
Notes: PRIMUS (aka EVIA or ENTOVIS) family of implantable pacemakers
Modular Type: Does not apply
Grant Notes  FCC Rule Parts Frequency
Range (MHZ) 		Output
Watts 		Frequency
Tolerance 		Emission
Designator
IT 95I 402.0  -  405.0 2E-7 1.95  PM 182KF1D

Output power is EIRP.


IT: Implanted Transmitter

Mail To:
Joerg Kusig, Head of Certification Department
Eurofins Product Service GmbH
Storkower Str. 38c
Reichenwalde, 15526
Germany