510(k) K220828 ยท POV Semen Analysis Device
SQA-iO Sperm Quality Analyzer
| Applicant | Medical Electronic Systems , Ltd., Caesarea, IL |
| Decision | Substantially Equivalent, Aug 7, 2023 |
| Received | Mar 22, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220828
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.