FDA 510(k) Application Details - K200136

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K200136
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	Wuxi Hisky Medical Technologies Co., Ltd. B401, 530 Plaza, University Science Park, Taihu International Science & Tech. Wuxi 214135 CN Other 510(k) Applications for this Company
Contact	Jinhua Shao Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	IYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/21/2020
Decision Date	03/17/2020
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