FDA 510(k) Application Details - K140163

Device Classification Name	Monitor, Uterine Contraction, External (For Use In Clinic)   More FDA Info for this Device
510(K) Number	K140163
Device Name	Monitor, Uterine Contraction, External (For Use In Clinic)
Applicant	CLINICAL INNOVATIONS, LLC 62 FOREST STREET, STE 300 MARLBOROUGH, MA 01752 US Other 510(k) Applications for this Company
Contact	JOANNE BRONIKOWSKI Other 510(k) Applications for this Contact
Regulation Number	884.2720   More FDA Info for this Regulation Number
Classification Product Code	HFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/22/2014
Decision Date	05/29/2014
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