Cereve Sleep System

Thermal System For Insomnia

CEREVE, INC.

The following data is part of a De Novo classification by Cereve, Inc. with the FDA for Cereve Sleep System.

Pre-market Notification Details

DeNovo IDDEN140032
Device Name:Cereve Sleep System
ClassificationThermal System For Insomnia
Applicant CEREVE, INC. 333 Allegheny Ave., 2nd Floor North Oakmont,  PA  15139
ContactEric Nofzinger
Product CodePLU  
CFR Regulation Number882.5700 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardNeurology
Classification AdvisoryNeurology
TypeDirect
Date Received2014-10-20
Decision Date2016-05-13
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

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