MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)

MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) is an FDA 510(k)-cleared medical device (K234080) manufactured by Soterix Medical, 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 24, 2024. Regulation: 8.