INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)

Generator, Oxygen, Portable

INOGEN, INC.

The following data is part of a premarket notification filed by Inogen, Inc. with the FDA for Inogen At Home Oxygen Concentrator (aka Inogen At Home).

Pre-market Notification Details

Device IDK132489
510k NumberK132489
Device Name:INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)
ClassificationGenerator, Oxygen, Portable
Applicant INOGEN, INC. 326 BOLLAY DRIVE Goleta,  CA  93117
ContactMara Korsunsky
CorrespondentMara Korsunsky
INOGEN, INC. 326 BOLLAY DRIVE Goleta,  CA  93117
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-08
Decision Date2014-06-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817131020148 K132489 000
00817131020131 K132489 000

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