Serenity Piezo Sensor, Serenity Thermocouple Sensor

Serenity Piezo Sensor, Serenity Thermocouple Sensor is an FDA 510(k)-cleared medical device (K181709) manufactured by Neurotronics, 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 November 15, 2018. Regulation: 8.