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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 supine sleep system
De Novo Number DEN210039
Device Name SNOO Smart Sleeper
Requester
Happiest Baby, Inc.
3115 s. la cienega blvd.
los angeles,  CA  90016
Contact harvey karp
Regulation Number880.5690
Classification Product Code
QTG  
Date Received09/20/2021
Decision Date 03/30/2023
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Reclassification Order Reclassification Order
Type Direct
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