BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TEMP-TESTER

    K Number: K771847 · Decision Nov 2, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    35

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    Basic Information

    Device Name
    TEMP-TESTER
    K Number
    K771847
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.1500
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Jablecki, Charles, Dr.
    Date Received
    September 28, 1977
    Decision Date
    November 2, 1977
    Product Code
    GXB
    Advisory Committee
    Neurology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXB Esthesiometer

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