510(k) K111505 ยท OBO Tomography, Optical Coherence
RTVUE CAM WITH CORNEAL POWER UPGRADE
| Applicant | Optovue, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Sep 8, 2011 |
| Received | May 31, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111505
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2012 | Optovue Inc. RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software) Terminated |
OBO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.