510(k) K101505 ยท HLI Ophthalmoscope, Ac-Powered
RTVUE MODEL RTVUE 100
| Applicant | Optovue, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Sep 15, 2010 |
| Received | Jun 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101505
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2012 | Optovue Inc. Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: Terminated |
OBO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.