
Monteris Medical,
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NeuroBlate Fusion-S Software V3.17 is an FDA 510(k)-cleared medical device (K222983) manufactured by Monteris Medical,. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 14, 2023. Regulation: 8.