K-number	K250860
Device name	BreatheBand® (Model 1000)
Applicant	Exemplar Medical, LLC
Product code	BYI
Device class	Class II
Decision date	Oct 2, 2025
Decision	Substantially Equivalent
Regulation	868.5665

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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BreatheBand® (Model 1000)

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