510(k) K002444

PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206 by Sun Nuclear Corp. — Product Code IYE

K002444 is an FDA 510(k) premarket notification submitted by Sun Nuclear Corp. for the device "PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206". The FDA issued a decision of Substantially Equivalent on October 18, 2000. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Sun Nuclear Corp. has at least 10 other 510(k) clearances on record.