FDA 510(k) Application Details - DEN170044

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170044
Device Name	ClearMate
Applicant	Thornhill Research, Inc. 210 Dundas St. W. Toronto M5G 2E8 CA Other 510(k) Applications for this Company
Contact	Kipton Lade Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/18/2017
Decision Date	03/14/2019
Decision	DENG -
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review