
Macosta Medical USA, LLC
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B-SMART, MODEL B-01 is an FDA 510(k)-cleared medical device (K031128) manufactured by Macosta Medical USA, LLC. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 14, 2004. Regulation: 8.