FDA 510(k) Application Details - K222787

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K222787
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	Chongqing Sunkingdom Medical Instrument Co., Ltd 1010, Block A of China Resource Center No.55 of XieJiaWan JiuLongPo Chongqing 400050 CN Other 510(k) Applications for this Company
Contact	Shulin Guo 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	09/15/2022
Decision Date	01/09/2023
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