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

    TRENDO-SCOPE

    K Number: K831995 · Decision Aug 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    48

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    Basic Information

    Device Name
    TRENDO-SCOPE
    K Number
    K831995
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1570
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Gabriel Ent.
    Date Received
    June 21, 1983
    Decision Date
    August 8, 1983
    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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    Other Clearances by Gabriel Ent.

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