FDA 510(k) Application Details - K231204

Device Classification Name	More FDA Info for this Device
510(K) Number	K231204
Device Name	CochlearÖ Osia« System; CochlearÖ Osia« OSI300 Implant; CochlearÖ Magnet Cassette; CochlearÖ Non-Magnetic Cassette; CochlearÖ Osia« 2(I) Sound Processor; CochlearÖ Osia« Fitting Software 2; CochlearÖ Osia« Smart App
Applicant	Cochlear 10350 Park Meadows Drive Lone Tree, CO 80124 US Other 510(k) Applications for this Company
Contact	Denis DiMartino 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	04/27/2023
Decision Date	08/18/2023
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