Cleared Traditional

SleepStageML

K233438 · Beacon Biosignals, Inc. · Neurology

Mar 2024

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K233438 is an FDA 510(k) clearance for the SleepStageML, a Automatic Event Detection Software For Polysomnograph With Electroencephalograph (Class II — Special Controls, product code OLZ), submitted by Beacon Biosignals, Inc. (Boston, US). The FDA issued a Cleared decision on March 8, 2024, 147 days after receiving the submission on October 13, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K233438 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 13, 2023
Decision Date	March 08, 2024
Days to Decision	147 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OLZ — Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Automatically Mark Electroencephalograph And Polysomongraph Signals In Order To Aid In Identification Of Such Events And Annotation Of Prolonged Psg Traces; Automatically Calculate Simple Measures Obtained From Recorded Signals (e.g. Magnitude, Time, Frequency And Simple Statistical Measures Of Marked Events); All Output Subject To Verification By Qualified User