Cleared Traditional

CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories

K211171 · GE Healthcare Finland Oy · Anesthesiology

Oct 2021

Decision

185d

Days

Class 2

Risk

About This 510(k) Submission

K211171 is an FDA 510(k) clearance for the CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories, 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 October 21, 2021, 185 days after receiving the submission on April 19, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number	K211171 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 19, 2021
Decision Date	October 21, 2021
Days to Decision	185 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF