510(k) K931801

MULTI-DOP X by Dantec Medical, Inc. — Product Code IYO

K931801 is an FDA 510(k) premarket notification submitted by Dantec Medical, Inc. for the device "MULTI-DOP X". The FDA issued a decision of Substantially Equivalent on June 14, 1995. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Dantec Medical, Inc. has at least 10 other 510(k) clearances on record.