K-number	K252525
Device name	AIO Breathe
Applicant	Aiomega, LLC
Product code	LRK
Device class	Class II
Decision date	Nov 6, 2025
Decision	Substantially Equivalent
Regulation	872.5570

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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AIO Breathe

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