BABYMEG BIOMAGNETOMETER SYSTEM

BABYMEG BIOMAGNETOMETER SYSTEM is an FDA 510(k)-cleared medical device (K133419) manufactured by Tristan Technologies, 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 July 20, 2014. Regulation: 8.