Cleared Traditional

INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)

K132489 · Inogen, Inc. · Anesthesiology
Jun 2014
Decision
316d
Days
Class 2
Risk

About This 510(k) Submission

K132489 is an FDA 510(k) clearance for the INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME), a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Inogen, Inc. (Goleta, US). The FDA issued a Cleared decision on June 20, 2014, 316 days after receiving the submission on August 8, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K132489 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2013
Decision Date June 20, 2014
Days to Decision 316 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAW — Generator, Oxygen, Portable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5440

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