| Device |
over-the-counter device to assess risk of sleep apnea |
| 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. |
| Physical State |
Software and/or Hardware. |
| Technical Method |
The principle of operation is based on analyzing physiological signals to assess Sleep Apnea. |
| Target Area |
Human body, Contactless or externally contacting device, Non-invasive, Non-implantable |
| Regulation Medical Specialty |
Anesthesiology |
| Review Panel |
Anesthesiology |
|---|
| Product Code | QZW |
|---|
| Premarket Review |
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
868.2378
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
