FCC ID QRIPRIMUSNXT
Medical Implant Pacemaker
by BIOTRONIK SE & Co. KG
Grantee Code: QRI Product Code: PRIMUSNXT
Latest application date: 2015-11-27
FCC ID Device Details
| FCC ID | QRIPRIMUSNXT |
|---|---|
| Mirrors | fcc.id | gov | fccid.ai |
| Grantee Code | QRI |
| Product Code | PRIMUSNXT |
| Applicant Business | BIOTRONIK SE & Co. KG 🇩🇪 |
| Related Domains |  biotronik.com |
| Equipment Class | Medical Implant Pacemaker |
| 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 | 2015-11-27 |
| 402.45-404.85 MHz | Original Equipment | 2013-12-11 |
Exhibits
| Document | Type | Available | File |
|---|---|---|---|
| 08_PRIMUSNXT ExtPho | External Photos | 2014-03-09 | PDF 173.1 KB |
| 06_07 Labeling_PRIMUSNXT | ID Label/Location Info | 2013-12-11 | PDF 398.2 KB |
| 17_PRIMUS-NXT AntSpec | Operational Description | 2015-11-27 | PDF 360.4 KB |
| 17_PRIMUSNXT AntSpec | Operational Description | 2013-12-11 | PDF 302.7 KB |
| 10_PRIMUS-NXT TSup | Test Setup Photos | 2015-11-27 | PDF 66.8 KB |
| 10_PRIMUSNXT Setup | Test Setup Photos | 2014-03-09 | PDF 60.1 KB |
| 14a_PRIMUS-NXT TestRep 95I | Test Report | 2015-11-27 | PDF 1.8 MB |
| 14b_PRIMUS-NXT TestRep | Test Report | 2015-11-27 | PDF 1.3 MB |
| 14a_PRIMUSNXT_TestRep_95I_without_product_photos_Rev01 | Test Report | 2013-12-11 | PDF 1.4 MB |
| 14b_PRIMUSNXT TestRep 15.209 without product photos | Test Report | 2013-12-11 | PDF 956.9 KB |
| 04_PRIMUS-NXT AutLet-U | Attestation Statements | 2015-11-27 | PDF 334.2 KB |
| 2013-10-18 Response EA310957rev1 | Attestation Statements | 2013-12-11 | PDF 66.6 KB |
| 05_PRIMUS-NXT ConReq-U | Cover Letter(s) | 2015-11-27 | PDF 424.2 KB |
| 22_PRIMUS-NXT FamList | Cover Letter(s) | 2015-11-27 | PDF 10.3 KB |
| 30_PRIMUS-NXT Class II Perm Change Letter | Cover Letter(s) | 2015-11-27 | PDF 366.9 KB |
| 04_PrimusNXT_HH_ AutLet-U | Cover Letter(s) | 2013-12-11 | PDF 269.6 KB |
| 05_PRIMUSNXT ConReq-U rev1 | Cover Letter(s) | 2013-12-11 | PDF 362.3 KB |
| 24_PRIMUSNXT ShortConReq rev1 | Cover Letter(s) | 2013-12-11 | PDF 363.4 KB |
| 18a_PRIMUSNXT RFExp | RF Exposure Info | 2013-12-11 | PDF 731.7 KB |
| 09_PRIMUS-NXT IntPho Metadata only | Internal Photos | PDF 66.1 KB | |
| 12_PRIMUS-NXT BlkDia Metadata only | Block Diagram | PDF 28.6 KB | |
| 13a_PRIMUS-NXT Schem Metadata only | Schematics | PDF 92 KB | |
| 13b_PRIMUS-NXT Schem Metadata only | Schematics | PDF 94.5 KB | |
| 11_PRIMUS-NXT OpDes Metadata only | Operational Description | PDF 34.4 KB | |
| 16a_PRIMUS-NXT PartsLst Metadata only | Parts List/Tune Up Info | PDF 39.9 KB | |
| 16b_PRIMUS-NXT PartsLst Metadata only | Parts List/Tune Up Info | PDF 42.7 KB |
Application Information
| Application ID | +kyVnFDwK/WGrOsLZprEJw== |
|---|---|
| Final Action Date | 2015-11-27 |
| Application Purpose | Class II permissive change or modification of presently authorized equipment |
| Applicant FRN | 0008008591 |
| Model | PRIMUSNXT |
| Frequency Range | 402.45-404.85 MHz |
| Equipment Class | TNT - Licensed Non-Broadcast Transmitter Worn on Body |
| Device Description | Medical Implant Pacemaker |
| Responsible Party | Gunnar Boersch, Team Manager Regulatory Affairs, gunnar.boersch@biotronik.com , +49-30-68905-0 |
| Technical Contact | Mark A Hillig, Micro Systems Engineering, mark.hillig@biotronik.com , 001503475 |
| Non-Technical Contact | Mark Briesemeister, Biotronik SE & Co. KG, mark.briesemeister@biotronik.com , 00493068905 |
| 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 | No |
| 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 EIRP |
Applications
| Application ID | Date | Purpose |
|---|---|---|
| +kyVnFDwK/WGrOsLZprEJw== | 2015-11-27 | Class II permissive change or modification of presently authorized equipment |
| DTWy9zoxZONLJAy1AThwjw== | 2013-12-11 | Original Equipment |
Equipment Authorization
Grants
TCB Grant - Application DTWy9zoxZONLJAy1AThwjw==
This application does not exist.
EAS Grant - Application DTWy9zoxZONLJAy1AThwjw==
| 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: 12/11/2013 Application Dated: 09/10/2013 |
| 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: | QRIPRIMUSNXT |
| 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 | 8E-7 | 9.0 PM | 188KF1D |
| Output power is EIRP. |
| IT: | Implanted Transmitter |
| Mail To: | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Joerg Kusig, | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Eurofins Product Service GmbH | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Storkower Str. 38C | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| , 15526 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Germany | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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: 11/27/2015 Application Dated: 11/27/2015 |
| 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: | QRIPRIMUSNXT |
| 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 | 8E-7 | 9.0 PM | 188KF1D |
| Output power is EIRP |
| IT: | Implanted Transmitter |
EAS Grant - Application +kyVnFDwK/WGrOsLZprEJw==
| 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: 11/27/2015 Application Dated: 11/27/2015 |
| 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: | QRIPRIMUSNXT |
| 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 | 8E-7 | 9.0 PM | 188KF1D |
| Output power is EIRP |
| IT: | Implanted Transmitter |
| Mail To: |