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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 K072527
Device Name AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
Applicant
ZOLL CIRCULATION
249 HUMBOLDT COURT
SUNNYVALE,  CA  94089
Applicant Contact MARK PERKINS
Correspondent
ZOLL CIRCULATION
249 HUMBOLDT COURT
SUNNYVALE,  CA  94089
Correspondent Contact MARK PERKINS
Regulation Number870.5200
Classification Product Code
DRM  
Date Received09/07/2007
Decision Date 03/19/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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