Cleared Traditional

FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM

K042419 · Draeger Medical, Inc. · Anesthesiology
Oct 2004
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K042419 is an FDA 510(k) clearance for the FABIUS GS/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 October 8, 2004, 31 days after receiving the submission on September 7, 2004. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K042419 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2004
Decision Date October 08, 2004
Days to Decision 31 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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