FDA 510(k) Application Details - K082480

Device Classification Name	Monitor, Ultrasonic, Fetal   More FDA Info for this Device
510(K) Number	K082480
Device Name	Monitor, Ultrasonic, Fetal
Applicant	CONTEC MEDICAL SYSTEM CO., LTD. SUITE 8D , ZHONGXIN ZHONGSHAN MANSION, NO. 19, LANE 999, ZHONG SHAN, SHANGHAI 20030 CN Other 510(k) Applications for this Company
Contact	Diana Hong Other 510(k) Applications for this Contact
Regulation Number	884.2660   More FDA Info for this Regulation Number
Classification Product Code	KNG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2008
Decision Date	02/25/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review