510(k) K162042 ยท LZF Pump, Infusion, Analytical Sampling
OptiScanner 5000 Glucose Monitoring System
| Applicant | Optiscan Biomedical Corp., Hayward CA, US |
| Decision | Substantially Equivalent, Oct 16, 2017 |
| Received | Jul 25, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162042
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.