Cleared Traditional

CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES

K123195 · GE Healthcare Finland Oy · Anesthesiology
Feb 2013
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K123195 is an FDA 510(k) clearance for the CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES, a Analyzer, Gas, Oxygen, Gaseous-phase (Class II — Special Controls, product code CCL), submitted by GE Healthcare Finland Oy (Helsinki, FI). The FDA issued a Cleared decision on February 28, 2013, 140 days after receiving the submission on October 11, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1720.

Submission Details

510(k) Number K123195 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 2012
Decision Date February 28, 2013
Days to Decision 140 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCL — Analyzer, Gas, Oxygen, Gaseous-phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1720