
Flaem Nuova S.P.A.
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FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB is an FDA 510(k)-cleared medical device (K062014) manufactured by Flaem Nuova S.P.A.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 21, 2007. Regulation: 8.