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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 K002548
Device Name FETAL ASSIST
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 Received08/17/2000
Decision Date 03/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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