HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING— 510(k) K133659

Substantially Equivalent

Philips Medical Systems

FDA 510(k) clearance K133659 for HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING, Substantially Equivalent on 2015-01-23. Applicant: Philips Medical Systems.

Clearance details

Applicant: Philips Medical Systems
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 2013-11-27
Decision date: 2015-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, 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.