FDA 510(k) Application Details - K231354

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K231354
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	Beijing Konted Medical Technology Co., Ltd. Room 111, 1F, Building 3, No. 27, Yong wang Road, Daxing Biological Pharmaceutical Industry Base Beijing 102629 CN Other 510(k) Applications for this Company
Contact	Deyi Zhu 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	05/10/2023
Decision Date	12/20/2023
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