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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
Predetermined Change
Control Plan Authorized		 No
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