INNOKAS MEDICAL OY

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2604-2016Class IICARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site July 27, 2016
Z-0264-2016Class IICARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humansOctober 22, 2015
Z-1022-2015Class IIVC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical December 3, 2014