REMI-AI Rapid Detection Module (REMI-AI RDM)— 510(k) K240408

Name: FDA 510(k) clearance K240408
Creator: U.S. Food and Drug Administration
Published: 2024-10-17

Substantially Equivalent

Epitel, Inc.

FDA 510(k) clearance K240408 for REMI-AI Rapid Detection Module (REMI-AI RDM), Substantially Equivalent on 2024-10-17. Applicant: Epitel, Inc.. Device class: 2.

Clearance details

Applicant: Epitel, Inc.
Product code: Code OMB
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2024-02-09
Decision date: 2024-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OMB

view all

K260998 — Ceribell Neurology Review Software2026-06-24
K252070 — Ceribell Infant Seizure Detection Software2025-11-21
K252160 — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))2025-10-31
K241589 — Ceribell Seizure Detection Software2025-04-09
K243743 — autoSCORE (V 2.0.0)2025-04-09

More clearances from Epitel, Inc.

view all

K231779 — REMI AI Discrete Detection Module2024-01-03
K230933 — REMI Remote EEG Monitoring System2023-06-30
K203827 — REMI2021-03-29

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