The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Drager Orm.
| Device ID | K790334 |
| 510k Number | K790334 |
| Device Name: | DRAGER ORM |
| Classification | Transducer, Gas Pressure, Differential |
| Applicant | DRAEGER MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYR |
| CFR Regulation Number | 868.2875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-02-16 |
| Decision Date | 1979-03-07 |