510(k) K021360

SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000 by Med-Tec,Inc. — Product Code KXK

K021360 is an FDA 510(k) premarket notification submitted by Med-Tec,Inc. for the device "SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000". The FDA issued a decision of Substantially Equivalent on June 10, 2003. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Med-Tec,Inc. has at least 7 other 510(k) clearances on record.