FDA 510(k) Application Details - K142799

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K142799
Device Name	System, Monitoring, Perinatal
Applicant	Bistos Co., Ltd. 27 New England Drive Ramsey, NJ 07446 US Other 510(k) Applications for this Company
Contact	Young Chi 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	09/29/2014
Decision Date	07/09/2015
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