Cleared Special

GE DATEX-OHMEDA AVANCE CS2

K131945 · Datex-Ohmeda · Anesthesiology
Aug 2013
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K131945 is an FDA 510(k) clearance for the GE DATEX-OHMEDA AVANCE CS2, a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ), submitted by Datex-Ohmeda (Madison, US). The FDA issued a Cleared decision on August 8, 2013, 42 days after receiving the submission on June 27, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K131945 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2013
Decision Date August 08, 2013
Days to Decision 42 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSZ — Gas-machine, Anesthesia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5160

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