510(k) K903821

PSC-1 W/OTHER NUMERICAL by Eigen — Product Code JAA

K903821 is an FDA 510(k) premarket notification submitted by Eigen for the device "PSC-1 W/OTHER NUMERICAL". The FDA issued a decision of Substantially Equivalent on November 7, 1990. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Eigen has at least 10 other 510(k) clearances on record.