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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 K063602
Device Name AUTOPULSE RESUSCITATION SYSTEM MODEL100
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 Received12/04/2006
Decision Date 12/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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