510(k) K192785 · LZF Pump, Infusion, Analytical Sampling
OptiScanner® 5000 Glucose Monitoring System
| Applicant | Optiscan Biomedical Corporation, Hayward CA, US |
| Decision | Substantially Equivalent, Feb 5, 2020 |
| Received | Sep 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192785
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.