FDA 510(k) Application Details - K241554

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K241554
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	Telefield Medical Imaging (Shenzhen) Limited Room A614-A619, A701-A703,National Key Lab Platform Building No.1Yuexing Second Road,Hi-tech Industrial Park,Nanshan Dist Shenzhen 518054 CN Other 510(k) Applications for this Company
Contact	Dolly Xiong 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	05/31/2024
Decision Date	10/24/2024
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