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510(k) Data Aggregation

    K Number
    K010482
    Device Name
    ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1
    Manufacturer
    ECHOCATH, INC.
    Date Cleared
    2001-03-20

    (28 days)

    Product Code
    JOP
    Regulation Number
    870.2880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ECHOCATH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990642
    Device Name
    ECHOFLOW DOPPLER BLOOD VELOCITY METER
    Manufacturer
    ECHOCATH, INC.
    Date Cleared
    1999-09-16

    (202 days)

    Product Code
    JOP, 74C
    Regulation Number
    870.2880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ECHOCATH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EchoFlow BVM-1 is an ultrasonic Doppler system that can be used to measure blood flow velocities. It can be used either for measurement of vessels below the skin, or for intraoperative measurements. It is not intended for cardiac or fetal use. A 10 MHz probe is supplied. The unit maintains its specified accuracy even if the angle between the probe face and vessel axis is as much as ±15°, unlike conventional Doppler systems where the angle between the flow direction and the probe must be accurately known. The unit can detect large blood vessels at depths up to 12 mm and small blood vessels at depths up to 10 mm in normal tissue. The system will not detect any signals from vessels more than 15.5 mm from the probe.
    Device Description
    The EchoFlow velocity system is a computer-based ultrasonic Doppler blood velocity measuring system used to measure blood velocity in vessels beneath the skin. It can either be used for measurement on the surface of the skin, or for intraoperative measurements. A 10 MHz CW probe is used. When used intraoperatively, a sterile sheath covers the probe and 6 feet of cable coming from the probe. A unique feature of the system is that the angle between the probe and the axis of the blood vessel does not have to be known. An accuracy of 15% is maintained if this angle changes by as much as ±15°. This is done by using a unique probe that emits two beams at known angles with respect to each other, as explained in a later section. Thus, the system is well-adapted to measuring flow in blood vessels beneath the surface of the skin, where the exact angle of the axis of the blood vessel cannot be determined. The unit can detect large blood vessels at depths up to 12 mm and small blood vessels at depths up to 10 mm in normal tissue. It will not detect any signals at depths greater than 15.5 mm from the probe tip.
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