Cleared Traditional

REMI

K203827 · Epitel, Inc. · Neurology

Mar 2021

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K203827 is an FDA 510(k) clearance for the REMI, a Reduced- Montage Standard Electroencephalograph (Class II — Special Controls, product code OMC), submitted by Epitel, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 29, 2021, 90 days after receiving the submission on December 29, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K203827 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 2020
Decision Date	March 29, 2021
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OMC — Reduced- Montage Standard Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A User-specified And/or Sponsor-specified Locations With A Reduced Array (i.e. Less Than < 16) Of Electrodes