Cleared Traditional

ZOLL E SERIES

K133239 · Zoll Medical Corporation, World Wide Headquarters · Cardiovascular

Jan 2015

Decision

452d

Days

Class 3

Risk

About This 510(k) Submission

K133239 is an FDA 510(k) clearance for the ZOLL E SERIES, 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 January 16, 2015, 452 days after receiving the submission on October 21, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K133239 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 21, 2013
Decision Date	January 16, 2015
Days to Decision	452 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.