Last synced on 19 July 2024 at 11:05 pm

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

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.2378
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QZW is linked to regulation 21CFR868.2378, which does not seem to exist yet. It may be pending at the moment.

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

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.2378
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QZW is linked to regulation 21CFR868.2378, which does not seem to exist yet. It may be pending at the moment.