510(k) K001203

OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT by The Olympus Optical Co. — Product Code ITX

K001203 is an FDA 510(k) premarket notification submitted by The Olympus Optical Co. for the device "OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT". The FDA issued a decision of Substantially Equivalent on May 26, 2000. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. The Olympus Optical Co. has at least 10 other 510(k) clearances on record.