510(k) K011877 ยท HKI Camera, Ophthalmic, Ac-Powered
FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM
| Applicant | Carl Zeiss Jena GmbH, Washington DC, US |
| Decision | Substantially Equivalent, Sep 26, 2001 |
| Received | Jun 15, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011877
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.