FDA 510(k) Application Details - K240155

Device Classification Name	More FDA Info for this Device
510(K) Number	K240155
Device Name	Cochlear Osia System
Applicant	Cochlear Americas 10350 Park Meadows Dr Lone Tree, CO 80124 US Other 510(k) Applications for this Company
Contact	Whitney Alexander 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	01/19/2024
Decision Date	04/18/2024
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