510(k) K243229

Bunkerhill AVC by BunkerHill Health — Product Code JAK

K243229 is an FDA 510(k) premarket notification submitted by BunkerHill Health for the device "Bunkerhill AVC". The FDA issued a decision of Substantially Equivalent on January 27, 2025. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. BunkerHill Health has at least 7 other 510(k) clearances on record.