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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name compressor, cardiac, external
510(k) Number K112998
Model MODEL 100
Device Name AUTOPULSE RESUSCITATION SYSTEM MODEL 1000
Original Applicant
ZOLL CIRCULATION
2000 ringwood ave
san jose,  CA  95131
Original Contact sam nanavati
Regulation Number870.5200
Classification Product Code
DRM  
Date Received10/07/2011
Decision Date 03/15/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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