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Proton Healthcare , Ltd.
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PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER; PROTON PHC 109 EAR THERMOMETER; PROTON 889 EAR THERMOMETER is an FDA 510(k)-cleared medical device (K051566) manufactured by Proton Healthcare , Ltd.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 16, 2006. Regulation: 8.

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