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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name over-the-counter device to assess risk of sleep apnea
De Novo Number DEN230041
Device Name Sleep Apnea Feature
Samsung Electronics Co., Ltd
129 samsung-ro, yeoungton-gu
suwon-si,  KR
Contact hon pak
Regulation Number868.2378
Classification Product Code
Date Received05/31/2023
Decision Date 02/06/2024
Decision granted (DENG)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct