K-number	K252105
Device name	Ligence Heart
Applicant	Ligence Uab
Product code	QIH
Device class	Class II
Decision date	Sep 26, 2025
Decision	Substantially Equivalent
Regulation	892.2050

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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Ligence Heart

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