FDA 510(k) Application Details - K250228

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K250228
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	eSonic Technology (Wuhan) Co., LTD Floor 7, Building B1, Block B, Phase II, High-tech Medical Devices Park, No.818 Gaoxin Avenue, East Lake High-tech Deve Wuhan 430206 CN Other 510(k) Applications for this Company
Contact	Souquet Jacques 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	01/27/2025
Decision Date	04/23/2025
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	N
Expedited Review