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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 K241368
Device Name Sonicaid Team3
Applicant
Huntleigh Healthcare Ltd.
35 Portmanmoor Road
Cardiff,  GB CF24 5HN
Applicant Contact Steve Monks
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number884.2740
Classification Product Code
HGM  
Date Received05/14/2024
Decision Date 02/03/2025
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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