FDA 510(k) Application Details - K243298

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K243298
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	Carbon (Shenzhen) Medical Device Co., Ltd. Room 203, Building B, 5# Skyworth Innovation Vally, No.1 Tangtou Road,Tangtou Community,Shiyan Street, Bao'an Disrict Shenzhen 518102 CN Other 510(k) Applications for this Company
Contact	Min Ye 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	10/18/2024
Decision Date	04/03/2025
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