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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 K122839
Device Name ZOLL SUREPOWER SINGLE BAY CHARGER
Applicant
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford,  MA  01824
Contact tanmay b shukla
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received09/18/2012
Decision Date 12/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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