FDA 510(k) Application Details - K223694

Device Classification Name	Masker, Tinnitus   More FDA Info for this Device
510(K) Number	K223694
Device Name	Masker, Tinnitus
Applicant	Duearity AB Krusegrand 42d Malmo 21225 SE Other 510(k) Applications for this Company
Contact	Anneli Johansson Other 510(k) Applications for this Contact
Regulation Number	874.3400   More FDA Info for this Regulation Number
Classification Product Code	KLW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2022
Decision Date	06/30/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review