The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Vamos Anesthetic Gas Monitor.
| Device ID | K012139 |
| 510k Number | K012139 |
| Device Name: | VAMOS ANESTHETIC GAS MONITOR |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| 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 | CCK |
| Subsequent Product Code | CBQ |
| Subsequent Product Code | DQA |
| Subsequent Product Code | NHO |
| Subsequent Product Code | NHQ |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-10 |
| Decision Date | 2002-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675227489 | K012139 | 000 |