FDA 510(k) Application Details - K191347

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K191347
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	Shenzhen Wisonic Medical Technology Co., Ltd. 1st, 2nd & 5th Floor, No. 6 Building, Pingshan Tech Park, Taoyuan Street, Nanshan Shenzhen 518055 CN Other 510(k) Applications for this Company
Contact	Jiang Xiaosan 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	05/20/2019
Decision Date	02/07/2020
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