The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Narkomed Mri , Nm-mri.
| Device ID | K001488 |
| 510k Number | K001488 |
| Device Name: | NARKOMED MRI , NM-MRI |
| Classification | Gas-machine, Anesthesia |
| Applicant | DRAEGER MEDICAL, INC. 3135 QUARRY RD. Telford, PA 18969 |
| Contact | J Teresa Dorreity, Jd |
| Correspondent | J Teresa Dorreity, Jd DRAEGER MEDICAL, INC. 3135 QUARRY RD. Telford, PA 18969 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-12 |
| Decision Date | 2000-06-09 |