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

    VARIABLE FOCUS 3.5 MHZ TRANSDUCER

    K Number: K812301 · Decision Nov 16, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    10
    Review Days
    94

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    Basic Information

    Device Name
    VARIABLE FOCUS 3.5 MHZ TRANSDUCER
    K Number
    K812301
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Adr Ultrasound
    Date Received
    August 14, 1981
    Decision Date
    November 16, 1981
    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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