Viterion TeleHealthcare Llc

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
1
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0820-2013Class IIViterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). PhysNovember 15, 2012
Z-0821-2013Class IIViterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patiNovember 15, 2012
Z-0822-2013Class IIViterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - PhysiNovember 15, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K030419VITERION 100 TELEHEALTH MONITORNovember 6, 2003