510(k) K002833

MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER by Standard Imaging, Inc. — Product Code KPT

K002833 is an FDA 510(k) premarket notification submitted by Standard Imaging, Inc. for the device "MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER". The FDA issued a decision of Substantially Equivalent on September 28, 2000. The device falls under product code KPT (Calibrator, Dose, Radionuclide), a Class II device regulated under 21 CFR 892.1360. Standard Imaging, Inc. has at least 9 other 510(k) clearances on record.