FDA 510(k) Application Details - K143114

Device Classification Name	Home Uterine Activity Monitor   More FDA Info for this Device
510(K) Number	K143114
Device Name	Home Uterine Activity Monitor
Applicant	AIRSTRIP TECHNOLOGIES, INC. 565 PLEARL ST. SUITE 209 LA JOLLA, CA 92037 US Other 510(k) Applications for this Company
Contact	ROBERT ANDREW MILLER Other 510(k) Applications for this Contact
Regulation Number	884.2730   More FDA Info for this Regulation Number
Classification Product Code	LQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2014
Decision Date	03/10/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review