BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC250

    K Number: K915647 · Decision Nov 9, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    8
    Review Days
    327

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    Basic Information

    Device Name
    DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC250
    K Number
    K915647
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pie Medical Equipment B.V.
    Date Received
    December 18, 1991
    Decision Date
    November 9, 1992
    Product Code
    ITX
    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
    ITX Transducer, Ultrasonic, Diagnostic

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