BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VASCUVIEW TAP ULTRASOUND SYSTEM

    K Number: K093613 · Decision Dec 23, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    3
    Review Days
    30

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    Basic Information

    Device Name
    VASCUVIEW TAP ULTRASOUND SYSTEM
    K Number
    K093613
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Escalon Medical Corp.
    Date Received
    November 23, 2009
    Decision Date
    December 23, 2009
    Product Code
    IYN
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

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    Other Clearances by Escalon Medical Corp.

    K Number Device Name
    K080049 VASCUVIEW ULTRASOUND SYSTEM
    K002920 MEGAVISION CPX, MEGAVISION FA, MODEL I AND II