PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380

PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 is an FDA 510(k)-cleared medical device (K002138) manufactured by Maersk Medical A/S. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 28, 2000. Regulation: 8.