510(k) K113129 ยท OBO Tomography, Optical Coherence
SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)
| Applicant | Heidelberg Engineering GmbH, Heidelberg, DE |
| Decision | Substantially Equivalent, Nov 8, 2011 |
| Received | Oct 24, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113129
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.