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

    T-METER

    K Number: K840487 · Decision Mar 12, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    35

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    Basic Information

    Device Name
    T-METER
    K Number
    K840487
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1570
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    K.J. Electronics
    Date Received
    February 6, 1984
    Decision Date
    March 12, 1984
    Product Code
    HCS
    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
    HCS Device, Temperature Measurement, Direct Contact, Powered

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