
Fego Precision Industrial Co;, Ltd.
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FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR is an FDA 510(k)-cleared medical device (K070209) manufactured by Fego Precision Industrial Co;, Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 7, 2007. Regulation: 8.