
Mallinckrodt Critical Care
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HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE is an FDA 510(k)-cleared medical device (K874514) manufactured by Mallinckrodt Critical Care. 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 28, 1988. Regulation: 8.

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