Cleared Traditional

Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector

K203762 · Covidien · Anesthesiology
Sep 2021
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K203762 is an FDA 510(k) clearance for the Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on September 17, 2021, 268 days after receiving the submission on December 23, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K203762 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2020
Decision Date September 17, 2021
Days to Decision 268 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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