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

    TYTRON C-3000

    K Number: K974208 · Decision Feb 3, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    85

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    Basic Information

    Device Name
    TYTRON C-3000
    K Number
    K974208
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1570
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Titronics Research & Development Co.
    Date Received
    November 10, 1997
    Decision Date
    February 3, 1998
    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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