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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 K132489
Device Name INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)
Applicant
INOGEN, INC.
326 BOLLAY DRIVE
GOLETA,  CA  93117
Applicant Contact MARA KORSUNSKY
Correspondent
INOGEN, INC.
326 BOLLAY DRIVE
GOLETA,  CA  93117
Correspondent Contact MARA KORSUNSKY
Regulation Number868.5440
Classification Product Code
CAW  
Date Received08/08/2013
Decision Date 06/20/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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