Cleared Traditional

DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM

K032803 · Datex-Ohmeda · Anesthesiology
Mar 2004
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K032803 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 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 March 10, 2004, 183 days after receiving the submission on September 9, 2003. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K032803 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2003
Decision Date March 10, 2004
Days to Decision 183 days
Submission Type Traditional
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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