POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A— 510(k) K091943

Name: FDA 510(k) clearance K091943
Creator: U.S. Food and Drug Administration
Published: 2009-09-10

Substantially Equivalent

Cardiac Science Corporation

FDA 510(k) clearance K091943 for POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A, Substantially Equivalent on 2009-09-10. Applicant: Cardiac Science Corporation. Device class: 3.

Clearance details

Applicant: Cardiac Science Corporation
Product code: Code MKJ
Device class: Class 3
Regulation: 21 CFR 870.5310
Advisory panel: Cardiovascular
Date received: 2009-06-30
Decision date: 2009-09-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

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K122758 — POWERHEART G5 AED2014-02-12
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K102496 — POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS2011-06-09
K093211 — CARECENTER MD2010-06-03
K082090 — 9131 DEFIBRILLATION ELECTRODES2008-12-12

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.