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

    DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System

    K Number: K201990 · Decision Nov 9, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    1117
    Applicant Total
    2
    Review Days
    115

    Basic Information

    Device Name
    DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System
    K Number
    K201990
    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 17, 2020
    Decision Date
    November 9, 2020
    Product Code
    IYN
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    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 Shenzhen Mindray Bio-medical Electronics Co., Ltd

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