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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodeQZW
Regulation Number 868.2378
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLE INC.
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG ELECTRONICS CO., LTD
  GRANTED 1

MDR Year MDR Reports MDR Events
2025 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Superficial (First Degree) Burn 1 1

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