510(k) K243114
K243114 is an FDA 510(k) premarket notification submitted by Medical Electronic Systems , Ltd. for the device "SQA-iOw Sperm Quality Analyzer". The FDA issued a decision of Substantially Equivalent on May 2, 2025. The device falls under product code POV (Semen Analysis Device), a Class II device regulated under 21 CFR 864.5220. Medical Electronic Systems , Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2025
- Date Received
- September 30, 2024
- Clearance Type
- Dual Track
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Semen Analysis Device
- Device Class
- Class II
- Regulation Number
- 864.5220
- Review Panel
- HE
- Submission Type
Device used to evaluate one or more human semen parameters including semen volume, sperm concentration, total sperm number, sperm motility, sperm morphology, sperm vitality, white blood cell concentration, and pH.