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Nien Made Electrnics Corp.
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NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1 is an FDA 510(k)-cleared medical device (K011310) manufactured by Nien Made Electrnics Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 19, 2001. Regulation: 8.