510(k) K120982 ยท HKI Camera, Ophthalmic, Ac-Powered
DIGITAL EYE-FUNDUS CAMERA
| Applicant | Medimaging Integrated Solutions, Inc. (Miis), Hsinchu, CN |
| Decision | Substantially Equivalent, Sep 28, 2012 |
| Received | Apr 2, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120982
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.