Cleared Traditional

INOGEN ONE OXYGEN CONCENTRATOR

K032818 · Inogen, Inc. · Anesthesiology
May 2004
Decision
246d
Days
Class 2
Risk

About This 510(k) Submission

K032818 is an FDA 510(k) clearance for the INOGEN ONE OXYGEN CONCENTRATOR, a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Inogen, Inc. (Goleta, US). The FDA issued a Cleared decision on May 13, 2004, 246 days after receiving the submission on September 10, 2003. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K032818 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2003
Decision Date May 13, 2004
Days to Decision 246 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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