FDA 510(k) Application Details - K234110

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K234110
Device Name	Oximeter
Applicant	Belun Technology Company Limited Flat/Rm 225B, 2/F, Building 1W, Phase One Hong Kong Science Park, Pak Shek Kok, N.T. Hong Kong HK Other 510(k) Applications for this Company
Contact	Lap Wai Lydia Leung Other 510(k) Applications for this Contact
Regulation Number	870.2700   More FDA Info for this Regulation Number
Classification Product Code	DQA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2023
Decision Date	10/11/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review