Devices · Beacon Biosignals, Inc.

Dreem 3S

Beacon Biosignals, Inc. is listed for Dreem 3S (K223539). The FDA list gives August 18, 2023 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code OLZ as “Automatic Event Detection Software For Polysomnograph With Electroencephalograph”: 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 openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223539

Official FDA database record

Date of final decision

August 18, 2023

Company on the FDA list

Beacon Biosignals, Inc.

Lead panel

Neurology

Primary product code

OLZ

openFDA device name for the code

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

Device class

2

Regulation number

882.1400

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary