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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Monitoring, Perinatal
510(k) Number K001677
Device Name BABY DOPPLEX 4000 (BD4000)
Applicant
HUNTLEIGH DIAGNOSTICS LTD.
35 PORTMANMOOR ROAD
CARDIFF WALES,  GB CF2 2HB
Applicant Contact B. J COLLEYPRIEST
Correspondent
HUNTLEIGH DIAGNOSTICS LTD.
35 PORTMANMOOR ROAD
CARDIFF WALES,  GB CF2 2HB
Correspondent Contact B. J COLLEYPRIEST
Regulation Number884.2740
Classification Product Code
HGM  
Date Received06/01/2000
Decision Date 08/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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