
Olympus America, Inc.
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ULTRASOUND GASTROSCOPE GF TYPE UM30P is an FDA 510(k)-cleared medical device (K963023) manufactured by Olympus America, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 6, 1997. Regulation: 8.