
Kmi Kolster Methods, Inc.
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XUB EXTERNAL ULTRASOUND is an FDA 510(k)-cleared medical device (K010702) manufactured by Kmi Kolster Methods, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 8, 2001. Regulation: 8.