FDA 510(k) Application Details - K143493

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K143493
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	Signostics Ltd 1284 South Road, Clovelly Park Pasadena SA 5042 AU Other 510(k) Applications for this Company
Contact	Stewart Bartlett 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	12/09/2014
Decision Date	01/14/2015
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