Devices · Samsung Electronics Co., Ltd

Sleep Apnea Feature

Samsung Electronics Co., Ltd is listed for Sleep Apnea Feature (DEN230041). The FDA list gives February 6, 2024 as the date of the final decision. The lead panel is Anesthesiology, and the database link on the FDA list is the De Novo pathway. openFDA describes product code QZW as “Over-The-Counter Device To Assess Risk Of Sleep Apnea”: An over-the-counter device to assess risk of sleep apnea is intended to provide a notification of the risk of sleep apnea in users who have not been previously diagnosed with sleep apnea. This device uses software algorithms to analyze input sensor signals and provide a risk assessment for sleep apnea. It is not intended to provide a standalone diagnosis, replace traditional methods of diagnosis (e.g., polysomnography), assist clinicians in diagnosing sleep disorders, or be used as an apnea monitor. openFDA records this submission’s decision description as “Unknown.” 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/denovo.cfm?id=DEN230041

Official FDA database record

Date of final decision

February 6, 2024

Company on the FDA list

Samsung Electronics Co., Ltd

Lead panel

Anesthesiology

Primary product code

QZW

openFDA device name for the code

Over-The-Counter Device To Assess Risk Of Sleep Apnea

Device class

2

Regulation number

868.2378

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned