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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K011461
Device Name ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR
Applicant
Access Cardiosystems, Inc.
150 Baker Ave. Extension
Suite 108
Concord,  MA  01742
Applicant Contact DAVID BARASH
Correspondent
Access Cardiosystems, Inc.
150 Baker Ave. Extension
Suite 108
Concord,  MA  01742
Correspondent Contact DAVID BARASH
Regulation Number870.5300
Classification Product Code
LDD  
Date Received05/14/2001
Decision Date 05/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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