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Epitel, Inc.

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories2
Latest FDA decision2024-10-17
TypeNumberDevice NameCodeDateActions
510(k) K240408 REMI-AI Rapid Detection Module (REMI-AI RDM)OMB2024-10-17 View
510(k) K231779 REMI AI Discrete Detection ModuleOMB2024-01-03 View
510(k) K230933 REMI Remote EEG Monitoring SystemOMC2023-06-30 View
510(k) K203827 REMIOMC2021-03-29 View