FDA 510(k) Application Details - K181574

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K181574
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	EchoNous, Inc. 8310 154th Ave NE Building B, Suite 200 Redmond, VA 98052 US Other 510(k) Applications for this Company
Contact	Trish Liau 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	06/15/2018
Decision Date	07/10/2018
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