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QZWClass II

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

21 CFR 868.2378 / Anesthesiology
FDA source (opens on fda.gov)

QZW is the FDA product code for Over-The-Counter Device To Assess Risk Of Sleep Apnea, a class II device type, regulated under 21 CFR 868.2378. FDA's definition for this code reads: "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...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QZW
Device name
Over-The-Counter Device To Assess Risk Of Sleep Apnea
FDA definition
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.
Regulation
21 CFR 868.2378
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code QZW

By decision year
3 clearances under product code QZW with a decision year between 2024 and 2026, 2024 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QZW by decision year
YearClearances
20242
20261

Applicants with the most clearances

Product code QZW
Applicants holding the most 510(k) clearances under product code QZW
ApplicantClearances
Samsung Electronics Co., Ltd.2
Apple Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code