Cleared Abbreviated

ONESTEP PEDIATRIC MFE'S

K110978 · ZOLL Medical Corporation · Cardiovascular

May 2011

Decision

36d

Days

Class 3

Risk

About This 510(k) Submission

K110978 is an FDA 510(k) clearance for the ONESTEP PEDIATRIC MFE'S, a Automated External Defibrillators (non-wearable) (Class III — Premarket Approval, product code MKJ), submitted by ZOLL Medical Corporation (Pawtucket, US). The FDA issued a Cleared decision on May 13, 2011, 36 days after receiving the submission on April 7, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K110978 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 07, 2011
Decision Date	May 13, 2011
Days to Decision	36 days
Submission Type	Abbreviated
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.