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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 K060230
Device Name DOPPLEX CENTRALE
Applicant
HUNTLEIGH HEALTHCARE LTD.
35 PORTMANMOOR RD.
CARDIFF, SOUTH GLAMORGAN,  GB CF24 5HN
Applicant Contact HUW JONES
Correspondent
TUV AMERICA, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number884.2740
Classification Product Code
HGM  
Date Received01/30/2006
Decision Date 03/23/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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