510(k) K891309

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

K891309 is an FDA 510(k) premarket notification submitted by Advanced Technology Laboratories, Inc. for the device "5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER". The FDA issued a decision of Substantially Equivalent on May 16, 1989. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Advanced Technology Laboratories, Inc. has at least 10 other 510(k) clearances on record.