Cleared Special

FABIUS TIRO ANESTHESIA SYSTEM

K031400 · Draeger Medical, Inc. · Anesthesiology
Jul 2003
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K031400 is an FDA 510(k) clearance for the 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 15, 2003, 71 days after receiving the submission on May 5, 2003. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K031400 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2003
Decision Date July 15, 2003
Days to Decision 71 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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