REMI Remote EEG Monitoring System— 510(k) K230933

Substantially Equivalent

Epitel, Inc.

FDA 510(k) clearance K230933 for REMI Remote EEG Monitoring System, Substantially Equivalent on 2023-06-30. Applicant: Epitel, Inc.. Device class: 2.

Clearance details

Applicant: Epitel, Inc.
Product code: Code OMC
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2023-04-03
Decision date: 2023-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OMC

K261101 — Ceribell Monitor2026-06-30
K251550 — NX01 (NX01)2025-11-25
K251726 — SignalNED System (Model RE)2025-09-03
K243185 — REMI Remote EEG Monitoring System2025-03-21
K242930 — Natus BrainWatch System2024-11-19

More clearances from Epitel, Inc.

K240408 — REMI-AI Rapid Detection Module (REMI-AI RDM)2024-10-17
K231779 — REMI AI Discrete Detection Module2024-01-03
K203827 — REMI2021-03-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.