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Healthstats International Pte. , Ltd.
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HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K060315) manufactured by Healthstats International Pte. , 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 April 6, 2006. Regulation: 8.