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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K032818
Device Name INOGEN ONE OXYGEN CONCENTRATOR
Applicant
INOGEN, INC.
120 CREMONA DRIVE
SUITE B
GOLETA,  CA  93117
Applicant Contact JOHN WELLS
Correspondent
INOGEN, INC.
120 CREMONA DRIVE
SUITE B
GOLETA,  CA  93117
Correspondent Contact JOHN WELLS
Regulation Number868.5440
Classification Product Code
CAW  
Date Received09/10/2003
Decision Date 05/13/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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