FDA 510(k) Application Details - K200644

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K200644
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	Siemens Medical Solutions USA, Inc 685 East Middlefield Road Mountain View, CA 94043 US Other 510(k) Applications for this Company
Contact	Shruti Arora 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	03/11/2020
Decision Date	04/10/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review