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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 K010889
Device Name BABY DOPPLEX 3000 MK 2 (BD3000)
Applicant
HUNTLEIGH HEALTHCARE, INC.
35 PORTMANMOOR ROAD
CARDIFF,  GB CF24 5HN
Applicant Contact B.J. COLLEYPRIEST
Correspondent
HUNTLEIGH HEALTHCARE, INC.
35 PORTMANMOOR ROAD
CARDIFF,  GB CF24 5HN
Correspondent Contact B.J. COLLEYPRIEST
Regulation Number884.2740
Classification Product Code
HGM  
Date Received03/26/2001
Decision Date 04/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Special
Reviewed by Third Party No
Combination Product No
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