FDA 510(k) Application Details - K221190

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K221190
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	Siemens Medical Solutions USA, Inc. 22010 South East 51st Street Issaquah, WA 98029 US Other 510(k) Applications for this Company
Contact	Sulgue Choi 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	04/25/2022
Decision Date	08/16/2022
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