510(k) K092813

ASTRASONIC SPIROMETER, MODEL 29-8000 by Sdi Diagnostics, Inc. — Product Code BZG

K092813 is an FDA 510(k) premarket notification submitted by Sdi Diagnostics, Inc. for the device "ASTRASONIC SPIROMETER, MODEL 29-8000". The FDA issued a decision of Substantially Equivalent on July 16, 2010. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Sdi Diagnostics, Inc. has at least 9 other 510(k) clearances on record.