FDA 510(k) Application Details - K191921

Device Classification Name	More FDA Info for this Device
510(K) Number	K191921
Device Name	Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments
Applicant	Cochlear Americas 13059 E Peakview Avenue Centennial, CO 80111 US Other 510(k) Applications for this Company
Contact	Chinda Hemmavanh 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	07/18/2019
Decision Date	11/15/2019
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