Cleared Traditional

OXYARM CO2

K014211 · Southmedic, Inc. · Anesthesiology
Jun 2002
Decision
172d
Days
Class 2
Risk

About This 510(k) Submission

K014211 is an FDA 510(k) clearance for the OXYARM CO2, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Southmedic, Inc. (Mccordsville, US). The FDA issued a Cleared decision on June 11, 2002, 172 days after receiving the submission on December 21, 2001. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K014211 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2001
Decision Date June 11, 2002
Days to Decision 172 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCK — Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1400

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