510(k) K243114 ยท POV Semen Analysis Device
SQA-iOw Sperm Quality Analyzer
| Applicant | Medical Electronic Systems , Ltd., Caesarea, IL |
| Decision | Substantially Equivalent, May 2, 2025 |
| Received | Sep 30, 2024 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K243114
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.