Cleared Traditional

Microstream CO2 NanoPod

K213911 · Covidien, LLC · Anesthesiology
Jul 2022
Decision
226d
Days
Class 2
Risk

About This 510(k) Submission

K213911 is an FDA 510(k) clearance for the Microstream CO2 NanoPod, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on July 29, 2022, 226 days after receiving the submission on December 15, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K213911 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2021
Decision Date July 29, 2022
Days to Decision 226 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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