K-number	DEN250005
Device name	Sana Device
Applicant	Sana Health
Product code	QYN
Device class	Class I
Decision date	Jan 16, 2026
Decision	Not Substantially Equivalent
Regulation	890.5775

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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Sana Device

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