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510(k) Data Aggregation

    K Number
    K972373
    Device Name
    OVATION HDP
    Manufacturer
    ORSONIQUE, INC.
    Date Cleared
    1997-07-29

    (34 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORSONIQUE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: ✔ 1. Slight ✔ 2. Mild ✔ 3. Moderate ✔ 4. Severe Configuration: ✔ 1. High Frequency - Precipitously Sloping ✔ 2. Gradually Sloping ✔ 3. Reverse Slope ✔ 4. Flat Other ✔ 1. Low tolerance To Loudness
    Device Description
    Not Found
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    K Number
    K963818
    Device Name
    OVATION AGC-2
    Manufacturer
    ORSONIQUE, INC.
    Date Cleared
    1996-10-28

    (35 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORSONIQUE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K963819
    Device Name
    OVATION ASP
    Manufacturer
    ORSONIQUE, INC.
    Date Cleared
    1996-10-28

    (35 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORSONIQUE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K963820
    Device Name
    OVATION LINEAR
    Manufacturer
    ORSONIQUE, INC.
    Date Cleared
    1996-10-28

    (35 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORSONIQUE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K963821
    Device Name
    OVATION AGC-1
    Manufacturer
    ORSONIQUE, INC.
    Date Cleared
    1996-10-28

    (35 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORSONIQUE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K963822
    Device Name
    OVATION AGC-3
    Manufacturer
    ORSONIQUE, INC.
    Date Cleared
    1996-10-28

    (35 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORSONIQUE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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