K241628
- 510(k) number
- K241628
- Device name
- YO Home Sperm Test
- Applicant
- Medical Electronic Systems , Ltd. IL
- Product code
- POV — Semen Analysis Device
- Decision date
- 2024-11-29
- Date received
- 2024-06-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K241628.pdf
Official FDA record: K241628
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.