Cleared Special

MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM

K041622 · Draeger Medical, Inc. · Anesthesiology
Jul 2004
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K041622 is an FDA 510(k) clearance for the MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM, a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ), submitted by Draeger Medical, Inc. (Telford, US). The FDA issued a Cleared decision on July 8, 2004, 22 days after receiving the submission on June 16, 2004. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K041622 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2004
Decision Date July 08, 2004
Days to Decision 22 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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