K Number
DEN240020Device Name
Visby Medical Women's Sexual Health TestManufacturer
Date Cleared
2025-03-28
(319 days)
Product Code
Regulation Number
866.3386Type
DirectPanel
MIReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A