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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 K032051
Device Name BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P
Applicant
Access Battery, Inc.
5357 Hwy. 86
Elizabeth,  CO  80107
Applicant Contact ALEXANDER B HENDERSON
Correspondent
Access Battery, Inc.
5357 Hwy. 86
Elizabeth,  CO  80107
Correspondent Contact ALEXANDER B HENDERSON
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received07/02/2003
Decision Date 01/09/2004
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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