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510(k) Data Aggregation

    K Number
    K030466
    Device Name
    HANDYDOP
    Manufacturer
    ELCAT, GMBH
    Date Cleared
    2003-09-12

    (212 days)

    Product Code
    KNG
    Regulation Number
    884.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELCAT, GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HandyDop™ is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, by means of continuous wave (doppler) echoscopy. The device is indicated for use to detect the flow of blood within the body. When using it with the 2 MHz probe, HandyDop™ is indicated for use for the early detection of fetal life, detection of multiple pregnancies, fetal screening from early gestation through delivery, and general indication of fetal well being. When using it with the 4 MHz or 8 MHz probes, HandyDop™ is indicated for use for detection of blood flow in the peripheral vascular system for assisting in the detection of peripheral vascular disease.
    Device Description
    The Handydop is a handheld, unidirectional, continuous wave (CW) Doppler with three changeable probes. 2MHz CW probe for foetal heartbeat detection, 4MHz CW probe and 8 MHz CW probe for peripheral vascular applications. You can hear the blood flow from a vein as a modulated noise on the speaker of the handydop. The Handydop works cordless with two 9V Battery's or Accumulators. The housings of the Handydop and the probes are made of ABS-plastics. The quartz crystals where encapsulated with Araldit-D (a Duroplastic). As control panel there are only the ON/OFF switch and the loudness wheel.
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