K000186 is an FDA 510(k) clearance for the DATEX-OHMEDA INOVENT DELIVERY SYSTEM. This device is classified as a Apparatus, Nitric Oxide Delivery (Class II - Special Controls, product code MRN).
Submitted by Datex-Ohmeda (Madison, US). The FDA issued a Cleared decision on February 10, 2000, 27 days after receiving the submission on January 14, 2000.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5165.
| 510(k) Number | K000186 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 2000 |
| Decision Date | February 10, 2000 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MRN — Apparatus, Nitric Oxide Delivery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5165 |