510(k) K061107

DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 by Thermo Electron OY — Product Code CEM

K061107 is an FDA 510(k) premarket notification submitted by Thermo Electron OY for the device "DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247". The FDA issued a decision of Substantially Equivalent on August 8, 2006. The device falls under product code CEM (Electrode, Ion Specific, Potassium), a Class II device regulated under 21 CFR 862.1600. Thermo Electron OY has at least 9 other 510(k) clearances on record.