REMI-AI Rapid Detection Module (REMI-AI RDM)

REMI-AI Rapid Detection Module (REMI-AI RDM) is an FDA 510(k)-cleared medical device (K240408) manufactured by Epitel, 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 October 16, 2024. Regulation: 8.