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

    GABRIEL DIGITREND

    K Number: K822795 · Decision Oct 8, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    22

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    Basic Information

    Device Name
    GABRIEL DIGITREND
    K Number
    K822795
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1570
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Gabriel Ent.
    Date Received
    September 16, 1982
    Decision Date
    October 8, 1982
    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.

    K Number Device Name
    K831995 TRENDO-SCOPE