Innovision A/S

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
10
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2769-2016Class IIInnocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic devicMay 13, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K151146N-Force Fixation SystemJuly 24, 2015
K132244N-FORCE FIXATION SYSTEMMarch 6, 2014
K102047LCI OPTION FOR INNOCORNovember 1, 2011
K102528N-FORCE FIXATION SYSTEMJuly 28, 2011
K083879INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00February 23, 2009
K071911CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCORSeptember 7, 2007
K051907INNOCORMarch 2, 2006
K011914HYDRO2, HS-75July 27, 2001
K000485HYDRO2, HS-75May 12, 2000
K944223ACCUCONDecember 7, 1994