Cleared Traditional

FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS

K011404 · Draeger Medical, Inc. · Anesthesiology
Feb 2002
Decision
290d
Days
Class 2
Risk

About This 510(k) Submission

K011404 is an FDA 510(k) clearance for the FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS, 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 February 22, 2002, 290 days after receiving the submission on May 8, 2001. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K011404 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2001
Decision Date February 22, 2002
Days to Decision 290 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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