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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
Device Name AUTOPULSE RESUSCITATION SYSTEM MODEL 1000
Applicant
ZOLL CIRCULATION
2000 Ringwood Ave
San Jose,  CA  95131
Applicant Contact SAM NANAVATI
Correspondent
ZOLL CIRCULATION
2000 Ringwood Ave
San Jose,  CA  95131
Correspondent Contact SAM NANAVATI
Regulation Number870.5200
Classification Product Code
DRM  
Date Received10/07/2011
Decision Date 03/15/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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