Cleared Traditional

CARESCAPE CO2 Microstream parameter

K213518 · Covidien, LLC · Anesthesiology
Apr 2022
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K213518 is an FDA 510(k) clearance for the CARESCAPE CO2 Microstream parameter, 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 April 12, 2022, 160 days after receiving the submission on November 3, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K213518 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2021
Decision Date April 12, 2022
Days to Decision 160 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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