510(k) K083291 ยท OBO Tomography, Optical Coherence
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000
| Applicant | Carl Zeiss Meditec, Inc., Dublin CA, US |
| Decision | Substantially Equivalent, May 5, 2009 |
| Received | Nov 7, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083291
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 2, 2011 | Carl Zeiss Meditec Inc Cirrus HD-OCT Model 400 instruments; new and refurbished, with or upgraded to, version 4.6 or 5.1.0 software.
The Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging Terminated |
OBO | None listed |
| May 2, 2011 | Carl Zeiss Meditec Inc Cirrus HD-OCT Model 4000 instruments, new and refurbished, distributed with, or upgraded to, version v 1.0 - 4.5, 5.0.0 or 5.1.0
The Cirrus HD-OCT is a non-contact, high resolution tomographic and bio Terminated |
OBO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.