FDA 510(k) Application Details - K190786

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K190786
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	Ellex Medical Pty Ltd. 3-4 Second Avenue Mawson Lakes Mawson Lakes 5095 AU Other 510(k) Applications for this Company
Contact	Andrew Pfeiffer 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	03/27/2019
Decision Date	04/11/2019
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