FDA 510(k) Application Details - K032818

Device Classification Name Generator, Oxygen, Portable

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510(K) Number K032818
Device Name Generator, Oxygen, Portable
Applicant INOGEN, INC.
120 CREMONA DRIVE
SUITE B
GOLETA, CA 93117 US
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Contact JOHN WELLS
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Regulation Number 868.5440

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Classification Product Code CAW
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Date Received 09/10/2003
Decision Date 05/13/2004
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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