FDA 510(k) Application Details - K090505

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K090505
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	SIGNOSTICS PTY LTD 13221 NE TEEM LOOP ROAD BAINBRIDGE ISLAND, WA 98110 US Other 510(k) Applications for this Company
Contact	CHARLES F HOTTINGER 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	02/26/2009
Decision Date	05/07/2009
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	N
Expedited Review