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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Active Implantable Bone Conduction Hearing System
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
Applicant Contact Chinda Hemmavanh
Correspondent
Cochlear Americas
13059 E Peakview Avenue
Centennial,  CO  80111
Correspondent Contact Chinda Hemmavanh
Regulation Number874.3340
Classification Product Code
PFO  
Date Received07/18/2019
Decision Date 11/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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