FDA 510(k) Application Details - K131941

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K131941
Device Name	System, Monitoring, Perinatal
Applicant	GUANGDONG BIOLIGHT MEDITECH CO., LTD P.O. BOX 120-119 SHANGHAI 200237 CN Other 510(k) Applications for this Company
Contact	Diana Hong 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	06/27/2013
Decision Date	05/15/2014
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