FDA 510(k) Application Details - K050167

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K050167
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	CHISON MEDICAL IMAGING CO., LTD. NO. 8, XIANG NAN ROAD SHUO FANG, NEW DISTRICT WUXI 214142 CN Other 510(k) Applications for this Company
Contact	MO RUOLI 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	01/26/2005
Decision Date	02/08/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review