Cleared Traditional

K091265 - ZOLL E SERIES WITH CPRREADYCHARGE
(FDA 510(k) Clearance)

K091265 · Zoll Medical Corporation, World Wide Headquarters · Cardiovascular

Dec 2009

Decision

237d

Days

Class 3

Risk

K091265 is an FDA 510(k) clearance for the ZOLL E SERIES WITH CPRREADYCHARGE, a Automated External Defibrillators (non-wearable) (Class III — Premarket Approval, product code MKJ), submitted by Zoll Medical Corporation, World Wide Headquarters (Chelmsford, US). The FDA issued a Cleared decision on December 23, 2009, 237 days after receiving the submission on April 30, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K091265 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 30, 2009
Decision Date	December 23, 2009
Days to Decision	237 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.