510(k) K173646

FS Ergo by Palodex Group OY — Product Code MUH

K173646 is an FDA 510(k) premarket notification submitted by Palodex Group OY for the device "FS Ergo". The FDA issued a decision of Substantially Equivalent on December 19, 2017. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Palodex Group OY has at least 9 other 510(k) clearances on record.