PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A— 510(k) K040904

Substantially Equivalent

Philips Medical Systems

FDA 510(k) clearance K040904 for PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A, Substantially Equivalent on 2004-09-16. Applicant: Philips Medical Systems.

Clearance details

Applicant: Philips Medical Systems
Product code: Code NSA
Advisory panel: Cardiovascular
Date received: 2004-04-07
Decision date: 2004-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

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Adverse events under product code NSA

product code NSA

Death: 21
Malfunction: 961
Total: 982

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.