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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name home uterine activity monitor
510(k) Number K143114
Device Name Sense4Baby System Model B+ (MSA)
Applicant
AIRSTRIP TECHNOLOGIES, INC.
565 PLEARL ST. SUITE 209
la jolla,  CA  92037
Applicant Contact robert andrew miller
Correspondent
CERTIFIED COMPLIANCE SOLUTIONS, INC.
11665 AVENA PLACE, SUITE 203
san diego,  CA  92128
Correspondent Contact curtis m egan
Regulation Number884.2730
Classification Product Code
LQK  
Subsequent Product Codes
HGM   MOH  
Date Received10/30/2014
Decision Date 03/10/2015
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
Recalls CDRH Recalls
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