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Colin Medical Instruments Corp.
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PRESS-MATE BX-10 VITAL SIGN MONITOR is an FDA 510(k)-cleared medical device (K032857) manufactured by Colin Medical Instruments 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 February 3, 2004. Regulation: 8.