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510(k) Data Aggregation

    K Number
    K053004
    Device Name
    MSAS-VANTAGE
    Manufacturer
    Date Cleared
    2006-01-13

    (79 days)

    Product Code
    Regulation Number
    882.1540
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMERIDIAN, INT.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MSAS -- Vantage intended use is for the measurement of Galvanic Skin Response.
    Device Description
    Not Found
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    K Number
    K993824
    Device Name
    MSAS PROFESSIONAL
    Manufacturer
    Date Cleared
    2000-01-20

    (69 days)

    Product Code
    Regulation Number
    882.1540
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMERIDIAN, INT.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MSA-21 intended use is for the measurement of Galvanic Skin Response
    Device Description
    Not Found
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