Cleared Traditional

Oxy2Pro

K222511 · Southmedic, Inc. · Anesthesiology
Nov 2023
Decision
459d
Days
Class 2
Risk

About This 510(k) Submission

K222511 is an FDA 510(k) clearance for the Oxy2Pro, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Southmedic, Inc. (Barrie, CA). The FDA issued a Cleared decision on November 21, 2023, 459 days after receiving the submission on August 19, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K222511 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2022
Decision Date November 21, 2023
Days to Decision 459 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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