FDA 510(k) Application Details - K173715

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K173715
Device Name	System, Monitoring, Perinatal
Applicant	AlertWatch, Inc. 1600 Huron Parkway, Bldg. 520, Ste. 2326 Ann Arbor, MI 48109 US Other 510(k) Applications for this Company
Contact	Justin Adams Other 510(k) Applications for this Contact
Regulation Number	884.2740   More FDA Info for this Regulation Number
Classification Product Code	HGM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2017
Decision Date	04/23/2018
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