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510(k) Data Aggregation

    K Number
    K041915
    Device Name
    HEMO-DOP
    Manufacturer
    DWL ELEKTRONISCHE SYSTEME GMBH
    Date Cleared
    2004-08-04

    (19 days)

    Product Code
    IYN
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    DWL ELEKTRONISCHE SYSTEME GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hemo-Dop® is a medical device to detect blood vessels supplying haemorrhoids and the subsequent HAL for haemornolds of state if and in. It can asso be assul as work opportunities in the used for measuring the Sciero-theraby and Banceries and veins subcutaneous.
    Device Description
    The Hemo-Dop® consists of two parts. A proctoscope with implemented ultrasound probe and a basic unit which processes and displays the ultrasound signals. The processes of 360° can be insonated. When the ultrasound radiation meets a blood vessel, the frequency shift can be heard and it is graphically displayed. With the bullent of the vessel but also the depth in which it hows. Through the user not only Knows the exact position of the vessel. Since in the area behind the linear the procloscope the user can logate the roose. The can be treated as outpatient of the black defitate the pattent doesn't ficed a general or lobal thabethesia and reliable evaluation of the blood flow signals of the extracranial and peripheral vessels.
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