NeuTrace EP Mapping System v.2.1

NeuTrace EP Mapping System v.2.1 is an FDA 510(k)-cleared medical device (K233160) manufactured by Anumana, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 24, 2023. Regulation: 8.