HEARTSTART MRX, MODEL M3535A— 510(k) K040404

Substantially Equivalent

Philips Medical Systems, Inc.

FDA 510(k) clearance K040404 for HEARTSTART MRX, MODEL M3535A, Substantially Equivalent on 2004-05-04. Applicant: Philips Medical Systems, Inc..

Clearance details

Applicant: Philips Medical Systems, Inc.
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 2004-02-17
Decision date: 2004-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

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Adverse events under product code MKJ

product code MKJ

Death: 961
Injury: 1,070
Malfunction: 90,719
Other: 8
Total: 92,758

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.