510(k) K182569 ยท OBO Tomography, Optical Coherence
Spectralis HRA+OCT and variants with High Magnification Module
| Applicant | Heidelberg Engineering GmbH, Heidelberg, DE |
| Decision | Substantially Equivalent, Oct 18, 2018 |
| Received | Sep 18, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182569
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.