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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 K132650
Device Name SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM
Applicant
Huntleigh Healthcare Limited
35 Portmanmoor Rd.
Cardiff,  GB CF24 5HN
Applicant Contact LAURA GARCIA DEACON
Correspondent
Huntleigh Healthcare Limited
35 Portmanmoor Rd.
Cardiff,  GB CF24 5HN
Correspondent Contact LAURA GARCIA DEACON
Regulation Number884.2740
Classification Product Code
HGM  
Date Received08/26/2013
Decision Date 02/07/2014
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
Predetermined Change
Control Plan Authorized		 No
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