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Vortran Medical Technology 1, Inc.
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VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM is an FDA 510(k)-cleared medical device (K041473) manufactured by Vortran Medical Technology 1, 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 July 14, 2004. Regulation: 8.