510(k) K934818

HAND HELD DENTAL X-RAY DEVICE by Dept. of the Army — Product Code IZL

K934818 is an FDA 510(k) premarket notification submitted by Dept. of the Army for the device "HAND HELD DENTAL X-RAY DEVICE". The FDA issued a decision of Substantially Equivalent on January 24, 1994. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Dept. of the Army has at least 4 other 510(k) clearances on record.