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

    TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA

    K Number: K092164 · Decision May 13, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    301

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    Basic Information

    Device Name
    TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA
    K Number
    K092164
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Delicate Electronics Co., Ltd.
    Date Received
    July 16, 2009
    Decision Date
    May 13, 2010
    Product Code
    OQQ
    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
    OQQ Diagnostic Ultrasonic Transducer, Robotic

    Other Clearances by Shenzhen Delicate Electronics Co., Ltd.

    K Number Device Name
    K122710 TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND