510(k) K895647

5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER by Advanced Technology Laboratories, Inc. — Product Code HGL

K895647 is an FDA 510(k) premarket notification submitted by Advanced Technology Laboratories, Inc. for the device "5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER". The FDA issued a decision of Substantially Equivalent on December 18, 1989. The device falls under product code HGL (Transducer, Ultrasonic, Obstetric), a Class II device regulated under 21 CFR 884.2960. Advanced Technology Laboratories, Inc. has at least 10 other 510(k) clearances on record.