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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 K852910
Device Name CARDIORATER CR7
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 Number870.2300
Classification Product Code
DRT  
Date Received07/09/1985
Decision Date 11/19/1985
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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