Over-The-Counter Device To Assess Risk Of Sleep Apnea
The over-the-counter device to assess risk of sleep apnea (product code QZW) is a Class 2 Anesthesiology device (regulation 868.2378) that uses software algorithms to analyze input sensor signals and provide a risk assessment for sleep apnea in users who have not been previously diagnosed with the condition. Requiring 510(k) clearance, it is not intended to provide a standalone diagnosis, replace polysomnography, assist clinicians in diagnosing sleep disorders, or serve as an apnea monitor. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QZW
- Device Class
- FDA class 2
- Regulation Number
- 868.2378
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.