Name: Predicase
Price: 199 USD

K-number	K251501
Device name	Visby Medical Men's Sexual Health Test
Applicant	Visby Medical, Inc.
Product code	QEP
Device class	Class II
Decision date	Oct 1, 2025
Decision	Substantially Equivalent
Regulation	866.3393

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 Men's Sexual Health Test

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