Cleared Traditional

ZOLL M SERIES WITH REAL CPR HELP

K062537 · ZOLL Medical Corporation · Cardiovascular

Feb 2007

Decision

183d

Days

Class 3

Risk

About This 510(k) Submission

K062537 is an FDA 510(k) clearance for the ZOLL M SERIES WITH REAL CPR HELP, a Automated External Defibrillators (non-wearable) (Class III — Premarket Approval, product code MKJ), submitted by ZOLL Medical Corporation (Chelmsford, US). The FDA issued a Cleared decision on February 28, 2007, 183 days after receiving the submission on August 29, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K062537 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 29, 2006
Decision Date	February 28, 2007
Days to Decision	183 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.