
Ultrasound Medical Devices, Inc.
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ULTRA DCI MODEL 5000 is an FDA 510(k)-cleared medical device (K100363) manufactured by Ultrasound Medical Devices, Inc.. 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 20, 2010. Regulation: 8.