510(k) K212409 ยท MRN Apparatus, Nitric Oxide Delivery
Ulspira TS Nitric Oxide Therapy System
| Applicant | Airgas Therapeutics, Houston TX, US |
| Decision | Substantially Equivalent, Jun 30, 2023 |
| Received | Aug 3, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212409
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.