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Proton Healthcare , Ltd.
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PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA is an FDA 510(k)-cleared medical device (K051565) manufactured by Proton Healthcare , 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 September 11, 2005. Regulation: 8.