Cleared Special

POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS

K102496 · Cardiac Science Corporation · Cardiovascular

Jun 2011

Decision

282d

Days

Class 3

Risk

About This 510(k) Submission

K102496 is an FDA 510(k) clearance for the POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS, a Automated External Defibrillators (non-wearable) (Class III — Premarket Approval, product code MKJ), submitted by Cardiac Science Corporation (Bothell, US). The FDA issued a Cleared decision on June 9, 2011, 282 days after receiving the submission on August 31, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K102496 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 2010
Decision Date	June 09, 2011
Days to Decision	282 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MKJ — Automated External Defibrillators (non-wearable)
Device Class	Class III — Premarket Approval
CFR Regulation	21 CFR 870.5310
Definition	This Device Is A Non-wearable Prescription Use Only Aed. These Are Devices That Include Automated External Defibrillation. Automated External Defibrillators Use External Pad-type Electrodes To Sense, Detect, Classify And Treat (with An Electrical Shock) Ventricular Fibrillation. These Devices Are Intended To Be Used On Suspected Victims Of Sudden Cardiac Arrest. A Person In Cardiac Arrest Is Unresponsive And Is Not Breathing Normally. The Device Can Be Sold With Prescription Only.