510(k) K223299 · EOQ Bronchoscope (Flexible Or Rigid)
Ambu® aScope 5 Broncho HD 5.0/2.2, Ambu® aScope 5 Broncho HD 5.6/2.8, Ambu® aView 2 Advance
| Applicant | Ambu A/S, Ballerup, DK |
| Decision | Substantially Equivalent, Jun 1, 2023 |
| Received | Oct 27, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223299
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2024 | Ambu Inc. Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2 Open, Classified |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.