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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K943278
Device Name TRACKER 2/TRACKER 3 HOLTER RECORDER
Applicant
Reynolds Medical , Ltd.
1-2 Harforde Ct., Foxholes
Business Park
Hertford,  GB SG13 7NW
Applicant Contact MICHAEL MAZE
Correspondent
Reynolds Medical , Ltd.
1-2 Harforde Ct., Foxholes
Business Park
Hertford,  GB SG13 7NW
Correspondent Contact MICHAEL MAZE
Regulation Number870.2800
Classification Product Code
DSH  
Date Received07/07/1994
Decision Date 10/20/1994
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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