510(k) K011619

PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT by Planmeca Oy — Product Code EHD

K011619 is an FDA 510(k) premarket notification submitted by Planmeca Oy for the device "PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT". The FDA issued a decision of Substantially Equivalent on June 29, 2001. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Planmeca Oy has at least 10 other 510(k) clearances on record.