TM-5 INTRACRANIAL PRESSURE MONITOR

TM-5 INTRACRANIAL PRESSURE MONITOR is an FDA 510(k)-cleared medical device (K802149) manufactured by Nicolet Biomedical Instruments. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 11, 1980. Regulation: 8.