FDA 510(k) Application Details - K160420

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K160420
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	Signostics Limited 1284 South Road Clovelly Park 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	02/16/2016
Decision Date	03/21/2016
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