510(k) K130656 ยท HKI Camera, Ophthalmic, Ac-Powered
IFUSION
| Applicant | Optovue, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Jul 3, 2013 |
| Received | Mar 12, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130656
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2017 | Optovue, Inc. iFusion, Device Listing Number D203271.
Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the r Terminated |
HKI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.