CARDIO-3 CHANNEL ELECTROCARDIOGRAPH— 510(k) K850454

Substantially Equivalent

Zimmer Elektromedizin GmbH

FDA 510(k) clearance K850454 for CARDIO-3 CHANNEL ELECTROCARDIOGRAPH, Substantially Equivalent on 1985-03-01. Applicant: Zimmer Elektromedizin GmbH.

Clearance details

Applicant: Zimmer Elektromedizin GmbH
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1985-02-06
Decision date: 1985-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 7910 Neu-Ulm, Germany, DE

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.