Cleared Special

CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO

K183394 · GE Healthcare Finland Oy · Anesthesiology
May 2019
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K183394 is an FDA 510(k) clearance for the CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by GE Healthcare Finland Oy (Helsinki, FI). The FDA issued a Cleared decision on May 1, 2019, 145 days after receiving the submission on December 7, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K183394 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 2018
Decision Date May 01, 2019
Days to Decision 145 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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