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FDA 510(k) Application Details - K230052
Device Classification Name
Generator, Oxygen, Portable
More FDA Info for this Device
510(K) Number
K230052
Device Name
Generator, Oxygen, Portable
Applicant
Inogen, Inc
301 Coromar Drive
Goleta, CA 93117 US
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Contact
Sandra LeClair
Other 510(k) Applications for this Contact
Regulation Number
868.5440
More FDA Info for this Regulation Number
Classification Product Code
CAW
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More FDA Info for this Product Code
Date Received
01/06/2023
Decision Date
06/30/2023
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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