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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated External Defibrillators (Non-Wearable)
510(k) Number K141795
Device Name BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500
Applicant
R & D Batteries, Inc.
2063 Woodbourne Ter.
Castle Rock,  CO  80104
Applicant Contact KAREN MANLEY
Correspondent
R & D Batteries, Inc.
2063 Woodbourne Ter.
Castle Rock,  CO  80104
Correspondent Contact KAREN MANLEY
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received07/03/2014
Decision Date 12/08/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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