The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda 5330 Agent Monitor.
| Device ID | K890606 |
| 510k Number | K890606 |
| Device Name: | OHMEDA 5330 AGENT MONITOR |
| Classification | Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) |
| Applicant | OHMEDA MEDICAL 355 INVERNESS DR.SOUTH Englewood, CO 80112 -5810 |
| Contact | Amrik Sikand |
| Correspondent | Amrik Sikand OHMEDA MEDICAL 355 INVERNESS DR.SOUTH Englewood, CO 80112 -5810 |
| Product Code | CBQ |
| CFR Regulation Number | 868.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-06 |
| Decision Date | 1989-04-20 |