ClearMate

Isocapnic Ventilation Device

Thornhill Research, Inc.

The following data is part of a De Novo classification by Thornhill Research, Inc. with the FDA for Clearmate.

Pre-market Notification Details

DeNovo IDDEN170044
Device Name:ClearMate
ClassificationIsocapnic Ventilation Device
Applicant Thornhill Research, Inc. 210 Dundas St. W. Toronto,  CA M5g 2e8
ContactKipton Lade
Product CodeQFB  
CFR Regulation Number868.5480 [🔎]
DecisionGranted (DENG)
Review Advisory BoardAnesthesiology
Classification AdvisoryGeneral Hospital
TypeDirect
Date Received2017-08-18
Decision Date2019-03-14
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
18071411282223 DEN170044 000

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.