Cleared Traditional

LIFEPAK 15 MONITOR/DEFIBRILLATOR

K103567 · Physio-Control, Inc. · Cardiovascular

Mar 2011

Decision

106d

Days

Class 3

Risk

About This 510(k) Submission

K103567 is an FDA 510(k) clearance for the LIFEPAK 15 MONITOR/DEFIBRILLATOR, a Automated External Defibrillators (non-wearable) (Class III — Premarket Approval, product code MKJ), submitted by Physio-Control, Inc. (Redmond, US). The FDA issued a Cleared decision on March 22, 2011, 106 days after receiving the submission on December 6, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K103567 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 06, 2010
Decision Date	March 22, 2011
Days to Decision	106 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.