510(k) K901308

SPIRO ANALYZER MODEL ST 250 by Futuremed Div. of Future Impex Corp. — Product Code BZG

K901308 is an FDA 510(k) premarket notification submitted by Futuremed Div. of Future Impex Corp. for the device "SPIRO ANALYZER MODEL ST 250". The FDA issued a decision of Substantially Equivalent on July 23, 1990. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Futuremed Div. of Future Impex Corp. has at least 10 other 510(k) clearances on record.