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510(k) Data Aggregation

    K Number
    K081781
    Device Name
    NUWAV
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES, CORP
    Date Cleared
    2008-07-09

    (15 days)

    Product Code
    IYO, AND, OYN
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    LABORIE MEDICAL TECHNOLOGIES, CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NuWav Ultrasound Probe System is intended to used to perform diagnostic general ultrasound studies including Fetal, Abdominal (Solid Organs, Aneurysms, bladder), Pediatric, Small organ (breast, thyroid, bladder, testes, prostate), Neonatal Cephalic, Cardiac, Trans-vaginal, Trans-rectal, Peripheral Vascular, and Musculoskeletal (Conventional and Superficial). The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles or other anatomical structures as well as performing Urodynamic Studies.
    Device Description
    Not Found
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    K Number
    K073552
    Device Name
    LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES, CORP
    Date Cleared
    2008-03-05

    (78 days)

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

    LABORIE MEDICAL TECHNOLOGIES, CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Laborie Urodynamic systems are intended for Urodynamics testing. The traditional equipment performs standard tests including uroflowmeter, cystometry, micturition, electromyography and urethral pressure profiles. The accessory to our standard equipment, Tetra, uses near infrared spectroscopy, for non-invasive testing of bladder activity, aiding in the diagnosis of patients with lower urinary tract symptoms - that is patients who suffer from Urinary Incontinence. All Urodynamic equipment including the Laborie Urodynamic System with Tetra Accessory are for use under the direction of a licensed physical or health care professional in an office or hospital setting.
    Device Description
    The complete device includes traditional Urodynamic system and the Tetra accessory. That is all the standard components, for uroflowmetry and pressure measurement, and the new non-invasive component the Tetra accessory to detect bladder activity.
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