Name: Predicase
Price: 199 USD

K-number	DEN240020
Device name	Visby Medical Women's Sexual Health Test
Applicant	Visby Medical, Inc.
Product code	SEA
Device class	Class II
Decision date	Mar 28, 2025
Decision	Not Substantially Equivalent
Regulation	866.3386

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Visby Medical Women's Sexual Health Test

Everything you need for a 510(k) submission. Nothing you don't.