
Biosound Esaote, Inc.
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AU5 ULTRASOUND IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K000931) manufactured by Biosound Esaote, 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 June 7, 2000. Regulation: 8.