510(k) K902582

ALLERGAN HUMPHREY A/B SCAN , MODEL 835 by Allergan Humphrey — Product Code IYO

K902582 is an FDA 510(k) premarket notification submitted by Allergan Humphrey for the device "ALLERGAN HUMPHREY A/B SCAN , MODEL 835". The FDA issued a decision of Substantially Equivalent on August 14, 1990. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Allergan Humphrey has at least 2 other 510(k) clearances on record.