Cleared Traditional

SomniCheck

K223676 · Brainmatterz, LLC · Neurology
Jun 2023
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K223676 is an FDA 510(k) clearance for the SomniCheck, a Amplifier, Physiological Signal (Class II — Special Controls, product code GWL), submitted by Brainmatterz, LLC (Richmond, US). The FDA issued a Cleared decision on June 1, 2023, 175 days after receiving the submission on December 8, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1835.

Submission Details

510(k) Number K223676 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 2022
Decision Date June 01, 2023
Days to Decision 175 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWL — Amplifier, Physiological Signal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1835