The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Narkomed M Anesthesia System (m).
| Device ID | K971425 |
| 510k Number | K971425 |
| Device Name: | NARKOMED M ANESTHESIA SYSTEM (M) |
| Classification | Gas-machine, Anesthesia |
| Applicant | DRAEGER MEDICAL, INC. 3135 QUARRY RD. Telford, PA 18969 |
| Contact | James J Brennon |
| Correspondent | James J Brennon 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 | 1997-04-17 |
| Decision Date | 1997-09-10 |
| Summary: | summary |