The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda 5250 Rgm (respiratory Gas Monitor).
| Device ID | K882743 |
| 510k Number | K882743 |
| Device Name: | OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR) |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | OHMEDA MEDICAL 355 INVERNESS DR.SOUTH Englewood, CO 80112 -5810 |
| Contact | Vander Wiede |
| Correspondent | Vander Wiede OHMEDA MEDICAL 355 INVERNESS DR.SOUTH Englewood, CO 80112 -5810 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-01 |
| Decision Date | 1988-08-24 |