FDA 510(k) Application Details - K242321

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K242321
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	EchoNous, Inc. 8310 154th Ave NE Redmond, WA 98052 US Other 510(k) Applications for this Company
Contact	Joshua Kim Other 510(k) Applications for this Contact
Regulation Number	892.1550   More FDA Info for this Regulation Number
Classification Product Code	IYN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/06/2024
Decision Date	04/25/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review