Inogen at Home Oxygen Concentrator (Aka Inogen at Home)

FDA 510(k) K132489 · Inogen, Inc.

Substantially Equivalent

510(k) numberK132489

Submission

Device name
Inogen at Home Oxygen Concentrator (Aka Inogen at Home)
Applicant
Inogen, Inc.
Goleta, CA, US
Received
August 8, 2013
Decision date
June 20, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CAW – Generator, Oxygen, Portable
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5440
Specialty
Anesthesiology

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Questions and answers

When was Inogen at Home Oxygen Concentrator (Aka Inogen at Home) cleared by the FDA?

Inogen at Home Oxygen Concentrator (Aka Inogen at Home) (K132489) received a 510(k) decision of Substantially Equivalent on June 20, 2014, 316 days after the submission was received.

What is the product code of K132489?

The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.