510(k) K163705

EzRay Air W by VATECH Co., Ltd. — Product Code EHD

K163705 is an FDA 510(k) premarket notification submitted by VATECH Co., Ltd. for the device "EzRay Air W". The FDA issued a decision of Substantially Equivalent on January 24, 2017. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. VATECH Co., Ltd. has at least 10 other 510(k) clearances on record.