K-number	DEN250012
Device name	LifeVac
Applicant	Lifevac, LLC
Product code	QXN
Device class	Class II
Decision date	Mar 4, 2026
Decision	Not Substantially Equivalent
Regulation	874.5400

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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LifeVac

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