510(k) K193481 ยท MRN Apparatus, Nitric Oxide Delivery
AeroNOx 2.0 Nitric Oxide Titration & Monitoring System
| Applicant | International Biomedical, Austin TX, US |
| Decision | Substantially Equivalent, Mar 10, 2020 |
| Received | Dec 17, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193481
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.