Cleared Special

EMMA Capnograph

K201590 · Masimo Corporation · Anesthesiology
Mar 2021
Decision
290d
Days
Class 2
Risk

About This 510(k) Submission

K201590 is an FDA 510(k) clearance for the EMMA Capnograph, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on March 29, 2021, 290 days after receiving the submission on June 12, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K201590 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2020
Decision Date March 29, 2021
Days to Decision 290 days
Submission Type Special
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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