Cleared Traditional

Dreem 3S

K223539 · Beacon Biosignals, Inc. · Neurology
Aug 2023
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K223539 is an FDA 510(k) clearance for the Dreem 3S, 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 August 18, 2023, 268 days after receiving the submission on November 23, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K223539 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2022
Decision Date August 18, 2023
Days to Decision 268 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