FDA 510(k) Application Details - K220922

Device Classification Name	More FDA Info for this Device
510(K) Number	K220922
Device Name	Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit
Applicant	Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 US Other 510(k) Applications for this Company
Contact	Samata Veluvolu 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	03/31/2022
Decision Date	07/27/2022
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