The following data is part of a premarket notification filed by Draeger Medical Ag & Co. Kg with the FDA for Fabius Mri.
| Device ID | K072884 |
| 510k Number | K072884 |
| Device Name: | FABIUS MRI |
| Classification | Gas-machine, Anesthesia |
| Applicant | DRAEGER MEDICAL AG & CO. KG 3135 Quarry Road Telford, PA 18969 |
| Contact | Kathy Anderson |
| Correspondent | Kathy Anderson DRAEGER MEDICAL AG & CO. KG 3135 Quarry Road 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 | 2007-10-09 |
| Decision Date | 2008-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675041498 | K072884 | 000 |