FDA 510(k) Application Details - K240614

Device Classification Name	More FDA Info for this Device
510(K) Number	K240614
Device Name	Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS
Applicant	Oticon Medical AB Datavagen 37 B Askim 436 32 SE Other 510(k) Applications for this Company
Contact	Pernilla Gustafsson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PFO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2024
Decision Date	07/10/2024
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