510(k) K240569

FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber by Fink Engineering Pty, Ltd. — Product Code CBF

K240569 is an FDA 510(k) premarket notification submitted by Fink Engineering Pty, Ltd. for the device "FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber". The FDA issued a decision of Substantially Equivalent on November 21, 2024. The device falls under product code CBF (Chamber, Hyperbaric), a Class II device regulated under 21 CFR 868.5470. Fink Engineering Pty, Ltd. has at least 1 other 510(k) clearance on record.