
Healthstats International Pte. , Ltd.
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A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200 is an FDA 510(k)-cleared medical device (K101002) 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 June 7, 2010. Regulation: 8.