Cleared Traditional

Inogen Rove 6

K230052 · Inogen, Inc. · Anesthesiology
Jun 2023
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K230052 is an FDA 510(k) clearance for the Inogen Rove 6, 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 30, 2023, 175 days after receiving the submission on January 6, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K230052 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 2023
Decision Date June 30, 2023
Days to Decision 175 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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