POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)— 510(k) K052161

Substantially Equivalent

Cardiac Science, Inc.

FDA 510(k) clearance K052161 for POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A), Substantially Equivalent on 2005-10-21. Applicant: Cardiac Science, Inc..

Clearance details

Applicant: Cardiac Science, Inc.
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 2005-08-09
Decision date: 2005-10-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, 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.