Fabius GS Anesthesia System; Fabius Tiro Anesthesia System
by Draeger Medical, Inc. 510(k)
Active
510(k) K042086
Overview
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.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK042086 | Date31 Aug 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- BSZ
- Models / Variants
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5160
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent