FDA 510(k) Application Details - K100079

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K100079
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	SHENZHEN WELL.D MEDICAL ELECTRONICS CO., LTD STE 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	892.1560   More FDA Info for this Regulation Number
Classification Product Code	IYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/12/2010
Decision Date	03/01/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review