510(k) K033123 ยท HLI Ophthalmoscope, Ac-Powered
STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE
| Applicant | Carl Zeiss Meditec, Inc., Dublin CA, US |
| Decision | Substantially Equivalent, Apr 20, 2004 |
| Received | Sep 30, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K033123
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2009 | Carl Zeiss Meditec Inc Stratus OCT Model 3000 instruments distributed with version 6.0.0 software, product number 2660021119710 (new instrument) or 2660022119710 (refurbished instrument), and Stratus 6.0.0 Software Kit, pro Terminated |
HLI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.