FDA 510(k) Application Details - K222262

Device Classification Name	More FDA Info for this Device
510(K) Number	K222262
Device Name	Sunrise
Applicant	Sunrise SA Chaussee de Marche 598/02 Namur 5101 BE Other 510(k) Applications for this Company
Contact	Gregoire Lejeune 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	07/28/2022
Decision Date	12/22/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review