510(k) K182376 ยท NFJ System, Image Management, Ophthalmic
Harmony
| Applicant | Topcon Medical Systems, Inc., Oakland NJ, US |
| Decision | Substantially Equivalent, Sep 28, 2018 |
| Received | Aug 31, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182376
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.