FDA 510(k) Application Details - K220403

Device Classification Name	More FDA Info for this Device
510(K) Number	K220403
Device Name	Vibe SF Self-Fitting Hearing Aid
Applicant	WSAUD A/S Nymollevej 6 Lynge 3540 DK Other 510(k) Applications for this Company
Contact	Kristine Klitgaard Pedersen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/11/2022
Decision Date	08/12/2022
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