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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 infant pulse rate and oxygen saturation monitor for over-the-counter use
De Novo Number DEN220091
Device Name Dream Sock
Requester
Owlet Baby Care, Inc.
3300 n. ashton blvd. suite 300
lehi,  UT  84043
Contact jim fidacaro
Regulation Number870.2705
Classification Product Code
QYU  
Date Received12/14/2022
Decision Date 11/08/2023
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Reclassification Order Reclassification Order
Type Direct
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