510(k) K062913

ASTRAGUARD PULMONARY FUNCTION FILTER by Sdi Diagnostics, Inc. — Product Code BZG

K062913 is an FDA 510(k) premarket notification submitted by Sdi Diagnostics, Inc. for the device "ASTRAGUARD PULMONARY FUNCTION FILTER". The FDA issued a decision of Substantially Equivalent on January 26, 2007. 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.