The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Fabius Gs Anesthesia System, Model Fabius Gs.
| Device ID | K011404 |
| 510k Number | K011404 |
| Device Name: | FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS |
| Classification | Gas-machine, Anesthesia |
| Applicant | DRAEGER MEDICAL, INC. 3135 QUARRY RD. Telford, PA 18969 |
| Contact | Michail A Kelhart |
| Correspondent | Michail A Kelhart DRAEGER MEDICAL, INC. 3135 QUARRY RD. Telford, PA 18969 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-08 |
| Decision Date | 2002-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675398240 | K011404 | 000 |