510(k) K241163 ยท OBO Tomography, Optical Coherence
SPECTRALIS with Flex Module
| Applicant | Heidelberg Engineering GmbH, Heidelberg, DE |
| Decision | Substantially Equivalent, Oct 11, 2024 |
| Received | Apr 26, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241163
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.