POWERHEART AED G3 PRO— 510(k) K040637

Substantially Equivalent

Cardiac Science, Inc.

FDA 510(k) clearance K040637 for POWERHEART AED G3 PRO, Substantially Equivalent on 2004-08-06. Applicant: Cardiac Science, Inc..

Clearance details

Applicant: Cardiac Science, Inc.
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 2004-03-10
Decision date: 2004-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edina, MN, 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.