510(k) K071911

CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR by Innovision A/S — Product Code DQK

K071911 is an FDA 510(k) premarket notification submitted by Innovision A/S for the device "CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR". The FDA issued a decision of Substantially Equivalent on September 7, 2007. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Innovision A/S has at least 9 other 510(k) clearances on record.