ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.— 510(k) K021251

Substantially Equivalent

Philips Medical Systems

FDA 510(k) clearance K021251 for ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I., Substantially Equivalent on 2002-05-07. Applicant: Philips Medical Systems.

Clearance details

Applicant: Philips Medical Systems
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2002-04-19
Decision date: 2002-05-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Andover, MA, US

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Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.