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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 road
hopkins, MN 55343
Contact
grady hannah
Regulation Number
882.5705
Classification Product Code
QMZ
Date Received
05/27/2020
Decision Date
11/06/2020
Decision
granted (DENG)
Classification Advisory Committee
Neurology
Review Advisory Committee
Neurology
Reclassification Order
Reclassification Order
FDA Review
Decision Summary
Type
Direct
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