FDA 510(k) Application Details - DEN210015

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN210015
Device Name	Sunrise Sleep Disorder Diagnostic Aid
Applicant	Sunrise ChaussΘe de Marche 569/13 Namur 5101 BE Other 510(k) Applications for this Company
Contact	Francois Naye Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/2021
Decision Date	01/07/2022
Decision	DENG -
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review