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Airon Corporation
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PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY is an FDA 510(k)-cleared medical device (K121379) manufactured by Airon Corporation. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 10, 2012. Regulation: 8.