510(k) K163195 ยท OBO Tomography, Optical Coherence
PRIMUS
| Applicant | Carl Zeiss Suzhou Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Jun 21, 2017 |
| Received | Nov 15, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163195
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.