The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Narkomed 6400, Model Nm6400.
| Device ID | K033498 |
| 510k Number | K033498 |
| Device Name: | NARKOMED 6400, MODEL NM6400 |
| Classification | Gas-machine, Anesthesia |
| Applicant | DRAEGER MEDICAL, INC. 3135 QUARRY RD. Telford, PA 18969 |
| Contact | Gale E Winarsky |
| Correspondent | Gale E Winarsky 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 | 2003-11-05 |
| Decision Date | 2004-04-26 |
| Summary: | summary |