FDA 510(k) Application Details - K243041

Device Classification Name	Hearing Aid, Bone Conduction   More FDA Info for this Device
510(K) Number	K243041
Device Name	Hearing Aid, Bone Conduction
Applicant	BHM-Tech Produktionsgesellschaft mbH Grafenschachen 242 Grafenschachen 7423 AT Other 510(k) Applications for this Company
Contact	Markus Hirtzi 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	09/27/2024
Decision Date	04/25/2025
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