510(k) K201300 ยท EOQ Bronchoscope (Flexible Or Rigid)
Airway Mobilescope
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Jan 26, 2021 |
| Received | May 15, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201300
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Mobile airway scope-diagnosis and observation to access airway anatomy,
endotracheal/endobronchial intubation and management.
Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2. Open, Classified |
EOQ | None listed |
| Aug 31, 2023 | Olympus Corporation of the Americas Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2. Open, Classified |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.