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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 K072596
Device Name LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500
Applicant
Amco International Manufacturing & Design, Inc.
377 Zane Ct.
Elizabeth,  CO  80107
Applicant Contact ALEXANDER B HENDERSON
Correspondent
Amco International Manufacturing & Design, Inc.
377 Zane Ct.
Elizabeth,  CO  80107
Correspondent Contact ALEXANDER B HENDERSON
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received09/14/2007
Decision Date 01/24/2008
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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