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510(k) Data Aggregation

    K Number
    K960503
    Device Name
    DANTEC DUET
    Manufacturer
    DANTEC MEDICAL, INC.
    Date Cleared
    1996-09-16

    (227 days)

    Product Code
    FEN
    Regulation Number
    876.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    DANTEC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dantec Duet™ system is intended for urodynamics testing. The Duet™ system is intended to assist practitioners in executing specific urodynamics test protocols, collecting data during protocol execution, analyzing collected data, preparing written reports and archiving patient and testing information. General indications for use include use in patients with lower urinary tract voiding or continence problems, and more specifically incontinent patients, patients with bladder outlet obstructions, patients with neurogenic bladder dysfunction and some children with complex voiding / incontinence problems.
    Device Description
    The Dantec Duet™ is a computerized urodynamics measurement system. The system consists of a mobile cart or "trolley" with the following components mounted on it: a 486 based computer, color monitor, printer, dedicated keyboard, digital and analog measurement electronics, Windows™ based application software, transducers for measuring EMG, pressure, flow and weight, infusion stand, puller with arm, CO₂ gas pump, water pump, patient interface module and patient connecting accessories.
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    K Number
    K950314
    Device Name
    DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)
    Manufacturer
    DANTEC MEDICAL, INC.
    Date Cleared
    1996-03-25

    (424 days)

    Product Code
    GXZ
    Regulation Number
    882.1350
    Why did this record match?
    Applicant Name (Manufacturer) :

    DANTEC MEDICAL, INC.

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