
Teleflexmedical, Inc.
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NEB-U-MASK SYSTEM, MODELS 1895, 1896 is an FDA 510(k)-cleared medical device (K080230) manufactured by Teleflexmedical, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 8, 2008. Regulation: 8.