The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda Model 5330 Anesthetic Monitor.
| Device ID | K931439 |
| 510k Number | K931439 |
| Device Name: | OHMEDA MODEL 5330 ANESTHETIC MONITOR |
| Classification | Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) |
| 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 | CBQ |
| CFR Regulation Number | 868.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-22 |
| Decision Date | 1993-10-19 |