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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 K171865
Device Name F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring
Applicant
Farus, LLC
1240 Keystone Way
Vista,  CA  92081
Applicant Contact Rahul Singh
Correspondent
Farus, LLC
1240 Keystone Way
Vista,  CA  92081
Correspondent Contact Rahul Singh
Regulation Number884.2740
Classification Product Code
HGM  
Date Received06/22/2017
Decision Date 08/24/2017
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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