
Microlife Intellectual Property GmbH
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MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BU1-4U is an FDA 510(k)-cleared medical device (K061558) manufactured by Microlife Intellectual Property GmbH. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 28, 2006. Regulation: 8.