
Sim Italia S.R.L.
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INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 (WITH AC POWER SUPPLY ACCESSORY) is an FDA 510(k)-cleared medical device (K971947) manufactured by Sim Italia S.R.L.. 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 2, 1997. Regulation: 8.

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