
Quanta Computer, Inc.
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QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200 is an FDA 510(k)-cleared medical device (K083078) manufactured by Quanta Computer, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 25, 2008. Regulation: 8.