Cleared Special

9131 DEFIBRILLATION ELECTRODES

K082090 · Cardiac Science Corporation · Cardiovascular

Dec 2008

Decision

141d

Days

Class 3

Risk

About This 510(k) Submission

K082090 is an FDA 510(k) clearance for the 9131 DEFIBRILLATION ELECTRODES, 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 December 12, 2008, 141 days after receiving the submission on July 24, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K082090 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 24, 2008
Decision Date	December 12, 2008
Days to Decision	141 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.