Echonous Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2325-2024Class IIKosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose May 9, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K242321KosmosApril 25, 2025
K233826KosmosAugust 29, 2024
K212100KosmosAugust 6, 2021
K193518KOSMOSMarch 26, 2020
K181574UscanJuly 10, 2018