510(k) K221257 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
SpectraWAVE Imaging System
| Applicant | Spectrawave, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Feb 28, 2023 |
| Received | May 2, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221257
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.