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FDA 510(k) Application Details - K190304
Device Classification Name
Generator, Oxygen, Portable
More FDA Info for this Device
510(K) Number
K190304
Device Name
Generator, Oxygen, Portable
Applicant
Qingdao Kingon Medical Science and Technology Co.
24th East Building, No. 252 Yanhe Road, Tianhe Industrial
Park, Huangdao
Qingdao CN
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Contact
Roman Huang
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
02/12/2019
Decision Date
02/29/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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