PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR— 510(k) K111693

Substantially Equivalent

Philips Medical Systems

FDA 510(k) clearance K111693 for PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR, Substantially Equivalent on 2011-10-28. Applicant: Philips Medical Systems.

Clearance details

Applicant: Philips Medical Systems
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 2011-06-16
Decision date: 2011-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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.