510(k) K183416 ยท EOB Nasopharyngoscope (Flexible Or Rigid)
Rhino-Laryngo Videoscope Olympus ENF-VT3
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Sep 6, 2019 |
| Received | Dec 10, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183416
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including
nasopharyngeal and trachea).
Model Numbers: ENF-T3, ENF-VT2, ENF-VT3. Open, Classified |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.