FDA 510(k) Application Details - K213424

Device Classification Name	More FDA Info for this Device
510(K) Number	K213424
Device Name	Jabra Enhance Plus
Applicant	GN Hearing A/S Lautrupbjerg 7 Ballerup DK-2750 DK Other 510(k) Applications for this Company
Contact	Lars Hagander 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	10/21/2021
Decision Date	01/19/2022
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