K-number	K250662
Device name	Bunkerhill MAC
Applicant	BunkerHill Health
Product code	JAK
Device class	Class II
Decision date	Oct 3, 2025
Decision	Substantially Equivalent
Regulation	892.1750

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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Bunkerhill MAC

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