
Fim Medical
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ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50 is an FDA 510(k)-cleared medical device (K050424) manufactured by Fim Medical. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 22, 2005. Regulation: 8.