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510(k) Data Aggregation

    K Number
    K970430
    Device Name
    ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI
    Manufacturer
    MIDWEST CITY HEARING AID CENTER
    Date Cleared
    1997-03-11

    (35 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K963604
    Device Name
    DYNAMIC EQ II - 2 CHANNEL WIDE DYNAMIC RANGE COMPRESSION
    Manufacturer
    MIDWEST CITY HEARING AID CENTER
    Date Cleared
    1996-09-27

    (18 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

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    K Number
    K963607
    Device Name
    HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL
    Manufacturer
    MIDWEST CITY HEARING AID CENTER
    Date Cleared
    1996-09-20

    (11 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

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