510(k) K183419 ยท EOQ Bronchoscope (Flexible Or Rigid)
EVIS EXERA III Bronchovideoscope Olympus BF-XT190
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Sep 5, 2019 |
| Received | Dec 10, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183419
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2023 | Olympus Corporation of the Americas EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190 Open, Classified |
EOQ | None listed |
| Aug 31, 2023 | Olympus Corporation of the Americas Olympus Bronchovideoscope, Models BF-XT190. Open, Classified |
EOQ | None listed |
| Jul 17, 2023 | Olympus Corporation of the Americas Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190 Open, Classified |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.