OptumHealth Care Solutions LLC

FDA Regulatory Profile

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
1
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1811-2024Class IOptum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion PumpApril 18, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K130971OPTUM TELEHEALTH APPLICATIONOctober 23, 2013