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 ID: DEN170044
• Device Name: ClearMate
• Classification: Isocapnic Ventilation Device
• Applicant: Thornhill Research, Inc. 210 Dundas St. W. Toronto, CA M5g 2e8
• Contact: Kipton Lade
• Product Code: QFB
• CFR Regulation Number: 868.5480 [🔎]
• Decision: Granted (DENG)
• Review Advisory Board: Anesthesiology
• Classification Advisory: General Hospital
• Type: Direct
• Date Received: 2017-08-18
• Decision Date: 2019-03-14
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
18071411282223	DEN170044	000
10807141000107	DEN170044	000