FDA 510(k) Application Details - K100626

Device Classification Name	Monitor, Ultrasonic, Fetal   More FDA Info for this Device
510(K) Number	K100626
Device Name	Monitor, Ultrasonic, Fetal
Applicant	SHENZHEN BIOCARE ELECTRONICS CO., LTD SUITE 5D, NO 19, LANE 999 ZHONGSHAN NO. 2 ROAD(S) SHANGHAI 200030 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	03/05/2010
Decision Date	05/21/2010
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