Cleared Special

GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM

K071142 · Datex-Ohmeda · Anesthesiology
Jun 2007
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K071142 is an FDA 510(k) clearance for the GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM, a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ), submitted by Datex-Ohmeda (Madison, US). The FDA issued a Cleared decision on June 6, 2007, 43 days after receiving the submission on April 24, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K071142 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2007
Decision Date June 06, 2007
Days to Decision 43 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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