The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda Model 5250 Rgm Monitor.
| Device ID | K920590 |
| 510k Number | K920590 |
| Device Name: | OHMEDA MODEL 5250 RGM MONITOR |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | OHMEDA MEDICAL 1315 W. LOUISVILLE DR. Louisville, CO 80027 |
| Contact | Kevin Morningstar |
| Correspondent | Kevin Morningstar OHMEDA MEDICAL 1315 W. LOUISVILLE DR. Louisville, CO 80027 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-10 |
| Decision Date | 1992-08-31 |