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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name detector and alarm, arrhythmia
510(k) Number K871344
Device Name PATHFINDER 3, AUTO SURVEYOR AND SURVEYOR
Applicant
REYNOLDS MEDICAL LTD.
CAWTHORNE HOUSE,51ST ANDREW
ST.HERTFORD
herts sg14 1hz,  GB
Applicant Contact armstrong
Correspondent
REYNOLDS MEDICAL LTD.
CAWTHORNE HOUSE,51ST ANDREW
ST.HERTFORD
herts sg14 1hz,  GB
Correspondent Contact armstrong
Regulation Number870.1025
Classification Product Code
DSI  
Date Received04/06/1987
Decision Date 10/20/1987
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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