The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Datex-ohmeda Inovent Delivery System.
| Device ID | K000186 |
| 510k Number | K000186 |
| Device Name: | DATEX-OHMEDA INOVENT DELIVERY SYSTEM |
| Classification | Apparatus, Nitric Oxide Delivery |
| Applicant | DATEX-OHMEDA PO BOX 7550 Madison, WI 53707 |
| Contact | Daniel Kosednar |
| Correspondent | Daniel Kosednar DATEX-OHMEDA PO BOX 7550 Madison, WI 53707 |
| Product Code | MRN |
| Subsequent Product Code | MRO |
| Subsequent Product Code | MRP |
| Subsequent Product Code | MRQ |
| CFR Regulation Number | 868.5165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-14 |
| Decision Date | 2000-02-10 |