510(k) K161194 ยท OBO Tomography, Optical Coherence
PLEX Elite 9000 SS-OCT
| Applicant | Carl Zeiss Meditec, Inc., Dublin CA, US |
| Decision | Substantially Equivalent, Oct 26, 2016 |
| Received | Apr 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161194
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2018 | Carl Zeiss Meditec, Inc. The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic i Terminated |
OBO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.