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

    TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND

    K Number: K122710 · Decision Feb 15, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    2
    Review Days
    164

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    Basic Information

    Device Name
    TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND
    K Number
    K122710
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Delicate Electronics Co., Ltd.
    Date Received
    September 4, 2012
    Decision Date
    February 15, 2013
    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 Delicate Electronics Co., Ltd.

    K Number Device Name
    K092164 TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA