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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 digital therapy device to reduce sleep disturbance for psychiatric conditions
De Novo Number DEN200033
Device Name NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable
Requester
nightware, inc.
153 ashley rd.
hopkins,  MN  55343
Contact grady hannah
Regulation Number882.5705
Classification Product Code
QMZ  
Date Received05/27/2020
Decision Date 11/06/2020
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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