Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Epitel, Inc.

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

Total Devices4
Categories2
Latest Approval2024-10-17
TypeNumberDevice NameCodeDate
510(k) K240408 REMI-AI Rapid Detection Module (REMI-AI RDM) OMB 2024-10-17 View
510(k) K231779 REMI AI Discrete Detection Module OMB 2024-01-03 View
510(k) K230933 REMI Remote EEG Monitoring System OMC 2023-06-30 View
510(k) K203827 REMI OMC 2021-03-29 View