510(k) K163519

RX DC by Cefla S.C. — Product Code EHD

K163519 is an FDA 510(k) premarket notification submitted by Cefla S.C. for the device "RX DC". The FDA issued a decision of Substantially Equivalent on January 13, 2017. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Cefla S.C. has at least 10 other 510(k) clearances on record.