510(k) K843996

TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER by Equilibrated Bio Systems, Inc. — Product Code BZG

K843996 is an FDA 510(k) premarket notification submitted by Equilibrated Bio Systems, Inc. for the device "TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER". The FDA issued a decision of Substantially Equivalent on November 20, 1984. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Equilibrated Bio Systems, Inc. has at least 6 other 510(k) clearances on record.