510(k) K895449

ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM by Ge Medical Systems Information Technologies — Product Code HGL

K895449 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Information Technologies for the device "ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 5, 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.