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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 K141231
Device Name ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY
Applicant
ZELLER POWER PRODUCTS (BATTERY BEAST, LLC)
3975 WEST POST ROAD
LAS VEGAS,  NV  89118
Applicant Contact DOUGLAS AUSTIN
Correspondent
ZELLER POWER PRODUCTS (BATTERY BEAST, LLC)
3975 WEST POST ROAD
LAS VEGAS,  NV  89118
Correspondent Contact DOUGLAS AUSTIN
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received05/13/2014
Decision Date 11/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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