510(k) K831497

SPIROMETRICS BREON 2400 & SMI 2400 by Spirometrics, Inc. — Product Code BZG

K831497 is an FDA 510(k) premarket notification submitted by Spirometrics, Inc. for the device "SPIROMETRICS BREON 2400 & SMI 2400". The FDA issued a decision of Substantially Equivalent on June 24, 1983. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Spirometrics, Inc. has at least 10 other 510(k) clearances on record.