K-number	K250039
Device name	HPACS
Applicant	Healthhub
Product code	LLZ
Device class	Class II
Decision date	Oct 3, 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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HPACS

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