ELECTROCARDIOGRAPH CM3000— 510(k) K813279

Substantially Equivalent

Philips Medical Systems (Cleveland), Inc.

FDA 510(k) clearance K813279 for ELECTROCARDIOGRAPH CM3000, Substantially Equivalent on 1981-12-14. Applicant: Philips Medical Systems (Cleveland), Inc..

Clearance details

Applicant: Philips Medical Systems (Cleveland), Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1981-11-23
Decision date: 1981-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.