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Eumedics Medizintechnik Und Marketing GmbH
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RESPIFIT S, MODEL RS-LR1001004 is an FDA 510(k)-cleared medical device (K080299) manufactured by Eumedics Medizintechnik Und Marketing GmbH. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 12, 2009. Regulation: 8.