510(k) K071396

CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS by Capintec, Inc. — Product Code KPT

K071396 is an FDA 510(k) premarket notification submitted by Capintec, Inc. for the device "CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS". The FDA issued a decision of Substantially Equivalent on June 28, 2007. The device falls under product code KPT (Calibrator, Dose, Radionuclide), a Class II device regulated under 21 CFR 892.1360. Capintec, Inc. has at least 10 other 510(k) clearances on record.