FDA 510(k) Application Details - K190540

Device Classification Name	Hearing Aid, Bone Conduction   More FDA Info for this Device
510(K) Number	K190540
Device Name	Hearing Aid, Bone Conduction
Applicant	Oticon Medical AB Datavagen 37 B Askim SE-436 32 SE Other 510(k) Applications for this Company
Contact	Lise Terkelsen Other 510(k) Applications for this Contact
Regulation Number	874.3300   More FDA Info for this Regulation Number
Classification Product Code	LXB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/2019
Decision Date	05/02/2019
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