Cleared Traditional

K171028 - CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories
(FDA 510(k) Clearance)

K171028 · GE Healthcare Finland Oy · Anesthesiology

Aug 2017

Decision

134d

Days

Class 2

Risk

K171028 is an FDA 510(k) clearance for the CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories. This device is classified as 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 August 17, 2017, 134 days after receiving the submission on April 5, 2017.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number	K171028 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 05, 2017
Decision Date	August 17, 2017
Days to Decision	134 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF