510(k) K230501 ยท BZG Spirometer, Diagnostic
Spirobank Oxi
| Applicant | Mir Medical International Research USA, New Berlin WI, US |
| Decision | Substantially Equivalent, Dec 15, 2023 |
| Received | Feb 24, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230501
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.