
Brain Temp, Inc.
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BrainTemp Neonate System (BTNeo System) is an FDA 510(k)-cleared medical device (DEN200042) manufactured by Brain Temp, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 28, 2022. Regulation: 8.