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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
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