FDA 510(k) Application Details - K153580

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K153580
Device Name	System, Monitoring, Perinatal
Applicant	GUANGDONG BIOLIGHT MEDITECH CO., LTD. NO. 2 INNOVATION FIRST ROAD TECHNOLOGY INNOVATION COAST, HI-TECH ZONE ZHUHAI 519085 CN Other 510(k) Applications for this Company
Contact	Jin Liang 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	12/15/2015
Decision Date	09/07/2016
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