The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Modification To Vamos Anesthetic Gas Monitor.
| Device ID | K040847 |
| 510k Number | K040847 |
| Device Name: | MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| 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 | CCK |
| Subsequent Product Code | CBQ |
| Subsequent Product Code | CBR |
| Subsequent Product Code | CBS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | NHO |
| Subsequent Product Code | NHP |
| Subsequent Product Code | NHQ |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-01 |
| Decision Date | 2004-06-17 |
| Summary: | summary |