510(k) K142423 ยท NFJ System, Image Management, Ophthalmic
EyeSuite Imaging
| Applicant | Haag-Streit AG, Koeniz, Bern, CH |
| Decision | Substantially Equivalent, Sep 10, 2014 |
| Received | Aug 28, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142423
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2017 | Haag-Streit USA Inc EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs). Terminated |
NFJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.