FDA 510(k) Application Details - K092619

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K092619
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	CIVCO 102 FIRST ST. SOUTH KALONA, IA 52247 US Other 510(k) Applications for this Company
Contact	JAMES LEONG 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	08/26/2009
Decision Date	11/13/2009
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