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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,  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
Predetermined Change
Control Plan Authorized		 No
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