510(k) K842261

OB ULTRASOUND LINEAR SCANNER 630 by Ge Medical Systems Information Technologies — Product Code HEM

K842261 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Information Technologies for the device "OB ULTRASOUND LINEAR SCANNER 630". The FDA issued a decision of Substantially Equivalent on September 19, 1984. The device falls under product code HEM (Imager, Ultrasonic Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.2225. Ge Medical Systems Information Technologies has at least 10 other 510(k) clearances on record.