FDA 510(k) Application Details - K083061

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K083061
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	ELLEX, INC. 9940 BUSINESS PARK DR. SUITE 165 SACRAMENTO, CA 95827 US Other 510(k) Applications for this Company
Contact	TOM DAVIS 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	10/14/2008
Decision Date	01/09/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review