Epitel, Inc.

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K243185REMI Remote EEG Monitoring SystemMarch 21, 2025
K240408REMI-AI Rapid Detection Module (REMI-AI RDM)October 17, 2024
K231779REMI AI Discrete Detection ModuleJanuary 3, 2024
K230933REMI Remote EEG Monitoring SystemJune 30, 2023
K203827REMIMarch 29, 2021