FDA 510(k) Application Details - K211746

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K211746
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	GuangDong Youkey Medical Co., Ltd. Unit 601, Block B, Building 1, B1 District, Hantian Technology City, Nanhai District Foshan 528203 CN Other 510(k) Applications for this Company
Contact	Hu Zeyi 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	06/07/2021
Decision Date	02/18/2022
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