FDA 510(k) Application Details - K123335

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K123335
Device Name	System, Monitoring, Perinatal
Applicant	SUNRAY MEDICAL APPARATUS CO., LTD. B102 NANSHAN MEDICAL DEVICES INDUSTRIAL PARK, NO. 1019 OF NANHAI AVE SHENZHEN, GUANGDONG 518067 CN Other 510(k) Applications for this Company
Contact	SABRINA WEI 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	10/26/2012
Decision Date	03/21/2013
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