K193481 is an FDA 510(k) clearance for the AeroNOx 2.0 Nitric Oxide Titration & Monitoring System. This device is classified as a Apparatus, Nitric Oxide Delivery (Class II - Special Controls, product code MRN).
Submitted by International Biomedical (Austin, US). The FDA issued a Cleared decision on March 10, 2020, 84 days after receiving the submission on December 17, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5165.
| 510(k) Number | K193481 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2019 |
| Decision Date | March 10, 2020 |
| Days to Decision | 84 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 |