FDA 510(k) Application Details - K032640

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K032640
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	U-SYSTEMS, INC. 2081 LONGDEN CIRCLE LOS ALTOS,, CA 94204 US Other 510(k) Applications for this Company
Contact	SHEILA W PICKERING 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	08/27/2003
Decision Date	09/11/2003
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