510(k) K050424

ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50 by Fim Medical — Product Code BZG

K050424 is an FDA 510(k) premarket notification submitted by Fim Medical for the device "ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50". The FDA issued a decision of Substantially Equivalent on June 23, 2005. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Fim Medical has at least 3 other 510(k) clearances on record.