Medical Device Manufacturer · US , Salt Lake City , UT

Epitel, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2021
4
Total
4
Cleared
0
Denied

FDA 510(k) cleared devices by Epitel, Inc. Neurology ✕

4 devices
1-4 of 4
Cleared Oct 17, 2024
REMI-AI Rapid Detection Module (REMI-AI RDM)
K240408 · OMB
Neurology · 251d
Cleared Jan 03, 2024
REMI AI Discrete Detection Module
K231779 · OMB
Neurology · 201d
Cleared Jun 30, 2023
REMI Remote EEG Monitoring System
K230933 · OMC
Neurology · 88d
Cleared Mar 29, 2021
REMI
K203827 · OMC
Neurology · 90d
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