510(k) K232919 · FDS Gastroscope And Accessories, Flexible/Rigid
Ambu® aScope Gastro Large; Ambu® aBox 2
| Applicant | Ambu A/S, Ballerup, DK |
| Decision | Substantially Equivalent, Apr 5, 2024 |
| Received | Sep 19, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232919
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.