K-number	DEN250023
Device name	Aurie System
Applicant	Cathbuddy, Inc.
Product code	SHV
Device class	Class II
Decision date	Apr 30, 2026
Decision	Not Substantially Equivalent
Regulation	—

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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Aurie System

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