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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 K200975
Device Name Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum
Applicant
Huntleigh Healthcare Limited
35 Portmanmoor Road
Cardiff,  GB CF24 5HN
Applicant Contact Steve Monks
Correspondent
Huntleigh Healthcare Limited
35 Portmanmoor Road
Cardiff,  GB CF24 5HN
Correspondent Contact Steve Monks
Regulation Number884.2740
Classification Product Code
HGM  
Date Received04/13/2020
Decision Date 06/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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