510(k) K221320 ยท OBO Tomography, Optical Coherence
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX
| Applicant | Nidek Co., Ltd., Gamagori, JP |
| Decision | Substantially Equivalent, Mar 30, 2023 |
| Received | May 6, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221320
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.