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Sensor Medics Corp.
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INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION is an FDA 510(k)-cleared medical device (K031745) manufactured by Sensor Medics Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 12, 2004. Regulation: 8.