FDA 510(k) Application Details - K233076

Device Classification Name	Probe, Blood-Flow, Extravascular   More FDA Info for this Device
510(K) Number	K233076
Device Name	Probe, Blood-Flow, Extravascular
Applicant	RWD Life Science Co., Ltd. 19F, Building 9A, Vanke Cloud City III, Liuxin 4 Street, Nanshan District Shenzhen 518000 CN Other 510(k) Applications for this Company
Contact	Xuhong Wang Other 510(k) Applications for this Contact
Regulation Number	870.2120   More FDA Info for this Regulation Number
Classification Product Code	DPT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2023
Decision Date	05/28/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review