Cleared Traditional

CO2 Mainstream Sensor

K221118 · Draegerwerk AG & CO Kgaa · Anesthesiology
Apr 2023
Decision
352d
Days
Class 2
Risk

About This 510(k) Submission

K221118 is an FDA 510(k) clearance for the CO2 Mainstream Sensor, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Draegerwerk AG & CO Kgaa (Luebeck, DE). The FDA issued a Cleared decision on April 5, 2023, 352 days after receiving the submission on April 18, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K221118 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2022
Decision Date April 05, 2023
Days to Decision 352 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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