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FDA 510(k)

EPR-200 PROGRAMMER MODEL 010

K-Number: K800376 · 1980-04-21

ApplicantBiotronik Sales, Inc.
Decision Date1980-04-21
Product CodeKRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EPR-200 PROGRAMMER MODEL 010 is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik Sales, Inc.. It received FDA 510(k) clearance on 1980-04-21 under 510(k) number K800376. The device is classified under product code KRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPR-200 PROGRAMMER MODEL 010?

EPR-200 PROGRAMMER MODEL 010 is a medical device that received FDA 510(k) clearance on 1980-04-21. The listed applicant is Biotronik Sales, Inc.. The 510(k) number is K800376.

When did EPR-200 PROGRAMMER MODEL 010 receive FDA 510(k) clearance?

EPR-200 PROGRAMMER MODEL 010 received FDA 510(k) clearance on 1980-04-21, under 510(k) number K800376.

Who is the listed applicant for EPR-200 PROGRAMMER MODEL 010?

The FDA 510(k) record lists Biotronik Sales, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPR-200 PROGRAMMER MODEL 010?

The FDA product code for EPR-200 PROGRAMMER MODEL 010 is KRG.

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Other records listing Biotronik Sales, Inc. as applicant

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K875199NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTORK853194ERA-20K860036EDP-20 PACEMAKERK863878TRIOS-M VS-1 PULSE GENERATORK863879NEOS-M VS-1 PULSE GENERATORK863480BIOTRONIK PERMANENT PACEMAKER ELECTRODE

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Related Devices (Code: KRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K933278INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04Intermedics, Inc.K884522MODEL 5650 OPTIMATE PERSONAL PROGRAMMERTeletronics, Inc.K880738MODEL 2331T PATIENT PROGRAMMERMedtronic VascularK882429MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004Tpl-Cordis, Inc.K864712MODEL 1740 PERSONAL POCKET PROGRAMMERTelectronics, Inc.K871986MODEL 5600B PROGRAMMER, PACEMAKERTelectronics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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