BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments

    K Number: K190589 · Decision Jul 3, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    10
    Applicant Total
    20
    Review Days
    118

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    Basic Information

    Device Name
    Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments
    K Number
    K190589
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3340
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cochlear Americas
    Date Received
    March 7, 2019
    Decision Date
    July 3, 2019
    Product Code
    PFO
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PFO Active Implantable Bone Conduction Hearing System

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    Other Clearances by Cochlear Americas

    K Number Device Name
    K240155 Cochlear Osia System
    K231604 Instrument Case
    K220922 Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit
    K212136 Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
    K202048 Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App
    K191921 Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments
    K182116 BA310 Abutment, BIA310 Implant/Abutment
    K171088 Cochlear Baha SoundArc
    K161123 Baha 5 Power Sound Processor
    K153245 Baha 5 Super Power Sound Processor
    Search all 20 clearances from Cochlear Americas →