FDA 510(k) Application Details - K243086

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K243086
Device Name	Oximeter
Applicant	Unimed Medical Supplies, Inc. Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan, Baoan District Shenzhen 518108 CN Other 510(k) Applications for this Company
Contact	Huanyu Zeng 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	09/30/2024
Decision Date	02/20/2025
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