510(k) K161493 ยท POV Semen Analysis Device
YO Home Sperm Test
| Applicant | Medical Electronic Systems , Ltd., Caesarea Ind. Park, IL |
| Decision | Substantially Equivalent, Nov 8, 2016 |
| Received | Jun 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161493
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.