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510(k) Data Aggregation

    K Number
    K142329
    Device Name
    BBS REVOLUTION
    Manufacturer
    dBMEDx INC.
    Date Cleared
    2014-12-15

    (117 days)

    Product Code
    IYOITX
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    dBMEDx INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BBS Revolution system projects ultrasound energy through the lower abdomen of the patient an image of the bladder, which is used to calculate bladder volume non-invasively.
    Device Description
    Not Found
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