Cleared Traditional

AirLife? Open Et Oxygen Mask, AirLife? Open Et+ Oxygen Mask

K230915 · Vyaire Medical, Inc. · Anesthesiology
Nov 2024
Decision
592d
Days
Class 2
Risk

About This 510(k) Submission

K230915 is an FDA 510(k) clearance for the AirLife? Open Et Oxygen Mask, AirLife? Open Et+ Oxygen Mask, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Vyaire Medical, Inc. (Mettawa, US). The FDA issued a Cleared decision on November 12, 2024, 592 days after receiving the submission on March 31, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K230915 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2023
Decision Date November 12, 2024
Days to Decision 592 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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