Cleared Traditional

PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR

K130684 · Philips Medical Systems · Cardiovascular

Oct 2013

Decision

219d

Days

Class 3

Risk

About This 510(k) Submission

K130684 is an FDA 510(k) clearance for the PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR, a Automated External Defibrillators (non-wearable) (Class III — Premarket Approval, product code MKJ), submitted by Philips Medical Systems (Bothell, US). The FDA issued a Cleared decision on October 18, 2013, 219 days after receiving the submission on March 13, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K130684 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 2013
Decision Date	October 18, 2013
Days to Decision	219 days
Submission Type	Traditional
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.