510(k) K250868 ยท OBO Tomography, Optical Coherence
SPECTRALIS HRA+OCT and variants
| Applicant | Heidelberg Engineering GmbH, Heidelberg, DE |
| Decision | Substantially Equivalent, May 12, 2025 |
| Received | Mar 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250868
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.