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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 K852799
Device Name 2006, 2010, 2011, 2012(CARDIAC DC DEFIBRILLATOR)
Applicant
Cardiac Recorders, Ltd.
34 Scarborough Rd.
London,  GB N4 4LU
Applicant Contact BEVIS
Correspondent
Cardiac Recorders, Ltd.
34 Scarborough Rd.
London,  GB N4 4LU
Correspondent Contact BEVIS
Regulation Number870.5300
Classification Product Code
LDD  
Date Received07/01/1985
Decision Date 09/16/1985
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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