FDA 510(k) Application Details - K202119

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K202119
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	Weipeng (Suzhou) Medical Devices Co., Ltd. Unit 207, Building B2, Biobay, 218 Xinghu St., Suzhou Industrial Park Suzhou 215123 CN Other 510(k) Applications for this Company
Contact	Bin Yang 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	07/30/2020
Decision Date	10/07/2020
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