The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Drager Baromed.
| Device ID | K840279 |
| 510k Number | K840279 |
| Device Name: | DRAGER BAROMED |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | DRAEGER MEDICAL, INC. PA |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-23 |
| Decision Date | 1984-03-02 |