
Biotronex Laboratory, Inc.
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TEMPERATURE MONITOR (W/PROBE) is an FDA 510(k)-cleared medical device (K792257) manufactured by Biotronex Laboratory, Inc.. 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 December 3, 1979. Regulation: 8.

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