Cleared Traditional

K132489 - INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME) (FDA 510(k) Clearance)

K132489 · Inogen, Inc. · Anesthesiology device

Jun 2014

Decision

316d

Days

Class 2

Risk

K132489 is an FDA 510(k) clearance for the INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME). This device is classified as 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 FDA review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number	K132489 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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