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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 K132918
Device Name SENSE-4BABY SYSTEM
Applicant
SENSE4BABY, INC.
3344 N. TORREY PINES COURT, STE 100
LA JOLLA,  CA  92037
Applicant Contact JACQUES GINESTET
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Regulation Number884.2740
Classification Product Code
HGM  
Subsequent Product Codes
HFM   KNG  
Date Received09/17/2013
Decision Date 11/22/2013
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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