Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments

Active Implantable Bone Conduction Hearing System

Cochlear Americas

The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Cochlear Osia Osi200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia Smartapp, Cochlear Osia Surgical Instruments.

Pre-market Notification Details

Device IDK191921
501k NumberK191921
Device Name:Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments
ClassificationActive Implantable Bone Conduction Hearing System
Applicant Cochlear Americas 13059 E Peakview Avenue Centennial,  CO  80111
ContactChinda Hemmavanh
CorrespondentChinda Hemmavanh
Cochlear Americas 13059 E Peakview Avenue Centennial,  CO  80111
Product CodePFO  
CFR Regulation Number874.3340 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyEar Nose & Throat
501k Review PanelEar Nose & Throat
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-18
Decision Date2019-11-15

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