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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K852887
Device Name CR5 CARDIAC MONITOR
Applicant
Cardiac Recorders, Ltd.
34 Scarborough Rd.
London,  GB N4 4LU
Applicant Contact KEITH I BEVIS
Correspondent
Cardiac Recorders, Ltd.
34 Scarborough Rd.
London,  GB N4 4LU
Correspondent Contact KEITH I BEVIS
Regulation Number870.2300
Classification Product Code
DRT  
Date Received07/09/1985
Decision Date 11/14/1985
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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