FDA 510(k) Application Details - K202389

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K202389
Device Name	Generator, Oxygen, Portable
Applicant	Foshan MIC Medical Technology Co., LTD U501-1,503, 5F, No.7 Building, Zone A Hantian Industrial Park 17th Shenhai R Foshan 528200 CN Other 510(k) Applications for this Company
Contact	Wu Huahong Other 510(k) Applications for this Contact
Regulation Number	868.5440   More FDA Info for this Regulation Number
Classification Product Code	CAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/2020
Decision Date	04/08/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review