The following data is part of a De Novo classification by Ohmeda Medical with the FDA for Ohmeda Inovent Delivery System.
| DeNovo ID | DEN000001 |
| Device Name: | OHMEDA INOVENT DELIVERY SYSTEM |
| Classification | Apparatus, Nitric Oxide Delivery |
| Applicant | OHMEDA MEDICAL p.o. Box 7550 Madison, WI 53707 -7550 |
| Contact | Daniel Kosednar |
| Product Code | MRN |
| CFR Regulation Number | 868.5165 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K974562 |
| Review Advisory Board | Anesthesiology |
| Classification Advisory | Anesthesiology |
| Type | Post-NSE |
| Date Received | 2000-01-07 |
| Decision Date | 2000-01-11 |
| Reclassification Order: | Reclassification Order |