510(k) K900966

EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE by Hitachi Medical Corp. of America — Product Code HGL

K900966 is an FDA 510(k) premarket notification submitted by Hitachi Medical Corp. of America for the device "EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE". The FDA issued a decision of Substantially Equivalent on September 12, 1990. The device falls under product code HGL (Transducer, Ultrasonic, Obstetric), a Class II device regulated under 21 CFR 884.2960. Hitachi Medical Corp. of America has at least 10 other 510(k) clearances on record.