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FDA 510(k) Application Details - K223740
Device Classification Name
Generator, Oxygen, Portable
More FDA Info for this Device
510(K) Number
K223740
Device Name
Generator, Oxygen, Portable
Applicant
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
NO.8, Shengchang West Road,
Danyang Economy Development Zone Danyang, Jiangsu, China
Jiangsu 212300 CN
Other 510(k) Applications for this Company
Contact
Heidi Zhang
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
12/14/2022
Decision Date
10/05/2023
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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