
Tomey Corp. USA
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UD-1000 ULTRASONIC A/B SCANNER is an FDA 510(k)-cleared medical device (K020151) manufactured by Tomey Corp. USA. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 9, 2002. Regulation: 8.