FDA 510(k) Application Details - K231979

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K231979
Device Name	Oximeter
Applicant	Shenzhen Mecun Medical Supply Co., Ltd. 2nd Level, 2nd Building, Fuqiang S&T Park, 6 Ailian Industrial Park, Zhugushi, Wulian Community Shenzhen 518000 CN Other 510(k) Applications for this Company
Contact	Zheng Bo 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	07/05/2023
Decision Date	08/16/2024
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