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

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

    K Number: K173369 · Decision Dec 13, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    9
    Review Days
    47

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    Basic Information

    Device Name
    DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
    K Number
    K173369
    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-Meidcal Electronics Co., Ltd.
    Date Received
    October 27, 2017
    Decision Date
    December 13, 2017
    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-Meidcal Electronics Co., Ltd.

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