510(k) K092019

MODEL 1014 PC ELECTROMETER by Sun Nuclear Corp. — Product Code IYE

K092019 is an FDA 510(k) premarket notification submitted by Sun Nuclear Corp. for the device "MODEL 1014 PC ELECTROMETER". The FDA issued a decision of Substantially Equivalent on September 15, 2009. 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.