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

    GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X

    K Number: K032656 · Decision Oct 30, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    2
    Review Days
    63

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    Basic Information

    Device Name
    GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X
    K Number
    K032656
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc
    Date Received
    August 28, 2003
    Decision Date
    October 30, 2003
    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 Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc

    K Number Device Name
    K040251 GE LOGIQ 9 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 2404587