K-number	DEN230051
Device name	Myocene
Applicant	Myocene
Product code	SDX
Device class	Class II
Decision date	Jan 17, 2025
Decision	Not Substantially Equivalent
Regulation	882.1871

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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Myocene

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