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    K Number
    K102138
    Device Name
    ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER
    Manufacturer
    EDAN INSTRUMENTS, INC.
    Date Cleared
    2010-10-28

    (90 days)

    Product Code
    MAA
    Regulation Number
    884.2660
    Why did this record match?
    Product Code :

    MAA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ultrasonic TableTop Doppler is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices. The 2 MHz and/or 3 MHz probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma. The 4 MHz, 5 MHz and/or 8 MHz vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.
    Device Description
    Ultrasonic TableTop Doppler provides the following primary features: - Basic parameters: FHR, blood flow - 240 seconds fetal heart sound record and playback - Infrared communication(for SD6 only) - Ni-MH battery for 20 hours continuous working of main unit - Li-ion battery for 2.5 hours continuous working of SD6 probe
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    K Number
    K090499
    Device Name
    LIFEDOP MODEL, L350R
    Manufacturer
    SUMMIT DOPPLER SYSTEMS, INC.
    Date Cleared
    2009-03-31

    (34 days)

    Product Code
    MAA
    Regulation Number
    884.2660
    Why did this record match?
    Product Code :

    MAA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Obstetrical: This product will be used to detect fetal heart beats as an aid for determining fetal viability. Vascular: This product will also be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.
    Device Description
    The LifeDop 350 Doppler is a portable, battery-powered ultrasound device used for detecting fetal heart beats and also for blood flow detection in veins and arteries. Primarily intended to be table-top, stand or wall mounted.
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