EPR-200 PROGRAMMER MODEL 010— 510(k) K800376

Substantially Equivalent

Biotronik Sales, Inc.

FDA 510(k) clearance K800376 for EPR-200 PROGRAMMER MODEL 010, Substantially Equivalent on 1980-04-21. Applicant: Biotronik Sales, Inc..

Clearance details

Applicant: Biotronik Sales, Inc.
Product code: Code KRG
Advisory panel: Cardiovascular
Date received: 1980-02-21
Decision date: 1980-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRG

product code KRG

Malfunction: 8,377
Total: 8,377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.