BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Z6 DIAGNOSTIC ULTRASOUND SYSTEM

    K Number: K122010 · Decision Jul 20, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    1117
    Applicant Total
    73
    Review Days
    11

    Basic Information

    Device Name
    Z6 DIAGNOSTIC ULTRASOUND SYSTEM
    K Number
    K122010
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
    Date Received
    July 9, 2012
    Decision Date
    July 20, 2012
    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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