510(k) K924164

DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT by Eigen — Product Code JAA

K924164 is an FDA 510(k) premarket notification submitted by Eigen for the device "DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT". The FDA issued a decision of Substantially Equivalent on November 23, 1992. 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.