Cleared Traditional

SignalNED System (Model RE)

K242306 · Forest Devices, Inc. · Neurology
Sep 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K242306 is an FDA 510(k) clearance for the SignalNED System (Model RE), a Reduced- Montage Standard Electroencephalograph (Class II — Special Controls, product code OMC), submitted by Forest Devices, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on September 4, 2024, 30 days after receiving the submission on August 5, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K242306 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2024
Decision Date September 04, 2024
Days to Decision 30 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