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Pneupac , Ltd.
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COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER is an FDA 510(k)-cleared medical device (K021841) manufactured by Pneupac , Ltd.. 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 16, 2003. Regulation: 8.