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

    5.0 IOP & 7.5 IOP PROBES

    K Number: K853432 · Decision Feb 7, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    42
    Review Days
    176

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    Basic Information

    Device Name
    5.0 IOP & 7.5 IOP PROBES
    K Number
    K853432
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1240
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Diasonics, Inc.
    Date Received
    August 15, 1985
    Decision Date
    February 7, 1986
    Product Code
    GXW
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GXW Echoencephalograph

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