510(k) K903316

ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER by Ge Medical Systems Information Technologies — Product Code HGL

K903316 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Information Technologies for the device "ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER". The FDA issued a decision of Substantially Equivalent on August 22, 1990. The device falls under product code HGL (Transducer, Ultrasonic, Obstetric), a Class II device regulated under 21 CFR 884.2960. Ge Medical Systems Information Technologies has at least 10 other 510(k) clearances on record.