MATRx Plus

Closed Loop Auto Titration Device For Oral Appliances

Zephyr Sleep Technologies

The following data is part of a De Novo classification by Zephyr Sleep Technologies with the FDA for Matrx Plus.

Pre-market Notification Details

DeNovo IDDEN170090
Device Name:MATRx Plus
ClassificationClosed Loop Auto Titration Device For Oral Appliances
Applicant Zephyr Sleep Technologies 610a 70 Ave Se Calgary,  CA T2h-2j6
ContactSabrina Bruehlmann
Product CodeQCJ  
CFR Regulation Number872.5571 [🔎]
DecisionGranted (DENG)
501(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 BoardDental
Classification AdvisoryDental
TypeDirect
Date Received2017-12-21
Decision Date2018-08-23
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

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