The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda Model 5330 Anesthetic Agent Monitor.
| Device ID | K962648 |
| 510k Number | K962648 |
| Device Name: | OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR |
| Classification | Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) |
| Applicant | OHMEDA MEDICAL 1315 W. LOUISVILLE DR. Louisville, CO 80027 |
| Contact | Bill Curnan |
| Correspondent | Bill Curnan 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 | 1996-07-08 |
| Decision Date | 1997-01-17 |
| Summary: | summary |