FDA 510(k) Application Details - K183041

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K183041
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	Wuhan Zoncare Bio-medical Electronics Co., Ltd Zoncare Building, #380, High-tech 2ND Road Eastlake high-tech district Wuhan 430206 CN Other 510(k) Applications for this Company
Contact	Chenglin Tian 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	11/01/2018
Decision Date	07/10/2019
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