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FABIUS GS ANESTHESIA SYSTEM - Fabius Gs Anesthesia System

by Draeger Medical, Inc.

510(k) K042086

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK042086 Date31 Aug 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BSZ
Models / Variants
Fabius Gs Anesthesia System
Device Class
Class II
Regulation
21 CFR Part 868.5160
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Fabius GS Anesthesia System and Fabius Tiro Anesthesia System are anesthesia machines designed for delivering anesthesia to patients. These systems are classified under the product code BSZ and are intended for use in anesthesiology.

The devices are manufactured by Draeger Medical, Inc. and received FDA 510(k) clearance in 2004. They are not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.

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