FDA 510(k) Application Details - K221089

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K221089
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	Sonoscape Medical Corp. Room 201&202, 12th Building, Shenzhen Software Park Phase II 1 Keji Middle 2nd Road, Yuehai Subdistrict, Nanshan Shenzhen 518057 CN Other 510(k) Applications for this Company
Contact	Toki Wu 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	04/13/2022
Decision Date	09/15/2022
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