Documento fuente o registro público
FDA 510(k) K220828 — SQA-iO Sperm Quality Analyzer
FDA 510(k) index record K220828. Device: SQA-iO Sperm Quality Analyzer. Applicant as listed: Medical Electronic Systems , Ltd.. Decision date: 2023-08-07.
Fuente
"device_name": "SQA-iO Sperm Quality Analyzer"
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Review and references
Automated FDA record verification
2026-10-20
2026-10-29
professional use
FDA 510(k) public index record K220828.
Device name: SQA-iO Sperm Quality Analyzer. Applicant as listed: Medical Electronic Systems , Ltd..
Decision date: 2023-08-07. Decision wording: Substantially Equivalent.
Product code: POV. Regulation: 21 CFR 864.5220. Medical specialty: Hematology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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