FDA 510(k) Application Details - K240676

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K240676
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	Vinno Technology (Suzhou) Co.,Ltd 5F Building A,4F Building C No. 27 Xinfa Rd. Suzhou Industrial Park Suzhou 215123 CN Other 510(k) Applications for this Company
Contact	Jeff Zhou 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	03/11/2024
Decision Date	12/16/2024
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