FDA 510(k) Application Details - K233394

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K233394
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	Synovis Micro Companies Alliance (A subsidiary of Baxter International Inc.) 439 Industrial Lane Birmingham, AL 35211 US Other 510(k) Applications for this Company
Contact	Julie Carlston 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	10/03/2023
Decision Date	01/28/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review