Cleared Traditional

CAIRE COMPANION 5 OXYGEN CONCENTRATOR

K121167 · Caire, Inc. · Anesthesiology
May 2012
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K121167 is an FDA 510(k) clearance for the CAIRE COMPANION 5 OXYGEN CONCENTRATOR, a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Caire, Inc. (Ball Ground, US). The FDA issued a Cleared decision on May 2, 2012, 15 days after receiving the submission on April 17, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K121167 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2012
Decision Date May 02, 2012
Days to Decision 15 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

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

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