510(k) K083879

INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500) by Innovision A/S — Product Code BZG

K083879 is an FDA 510(k) premarket notification submitted by Innovision A/S for the device "INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500)". The FDA issued a decision of Substantially Equivalent on February 23, 2009. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Innovision A/S has at least 9 other 510(k) clearances on record.