510(k) K193095 ยท FAJ Cystoscope And Accessories, Flexible/Rigid
Ambu aScope 4 Cysto
| Applicant | Ambu A/S, Ballerup, DK |
| Decision | Substantially Equivalent, Apr 2, 2020 |
| Received | Nov 7, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193095
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.