Cleared Traditional

LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR

K130454 · Physio-Control, Inc. · Cardiovascular

Aug 2013

Decision

180d

Days

Class 3

Risk

About This 510(k) Submission

K130454 is an FDA 510(k) clearance for the LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR, 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 August 21, 2013, 180 days after receiving the submission on February 22, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K130454 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 22, 2013
Decision Date	August 21, 2013
Days to Decision	180 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.