
The Olympus Optical Co.
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OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT is an FDA 510(k)-cleared medical device (K001203) manufactured by The Olympus Optical Co.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 25, 2000. Regulation: 8.