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510(k) Data Aggregation

    K Number
    K010665

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    Device Name
    TRANSAMERICA DIGITAL EMS
    Manufacturer
    TRANSAMERICA MEDICAL SYSTEMS
    Date Cleared
    2001-04-27

    (52 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Type
    Special
    Panel
    Physical Medicine
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    K020750
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K010782

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    Device Name
    TRANSAMERICAN TENS
    Manufacturer
    TRANSAMERICA MEDICAL SYSTEMS
    Date Cleared
    2001-04-27

    (43 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Type
    Special
    Panel
    Neurology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    K020749
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K961749

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    Device Name
    TRANSAMERICA ELECTRODE
    Manufacturer
    TRANSAMERICA MEDICAL SYSTEMS
    Date Cleared
    1996-06-21

    (88 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

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