The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Pendant Mount Narkomed 2c Anesthesiua System.
| Device ID | K945463 |
| 510k Number | K945463 |
| Device Name: | PENDANT MOUNT NARKOMED 2C ANESTHESIUA SYSTEM |
| Classification | Gas-machine, Anesthesia |
| Applicant | DRAEGER MEDICAL, INC. 3135 QUARRY RD. Telford, PA 18969 |
| Contact | James J Brennan |
| Correspondent | James J Brennan 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 | 1994-11-07 |
| Decision Date | 1995-02-03 |