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

    THERMAL GRAYSCALE RF-100

    K Number: K843836 · Decision Oct 19, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    86
    Applicant Total
    68
    Review Days
    18

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    Basic Information

    Device Name
    THERMAL GRAYSCALE RF-100
    K Number
    K843836
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.2810
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Fukuda Denshi USA, Inc.
    Date Received
    October 1, 1984
    Decision Date
    October 19, 1984
    Product Code
    DSF
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DSF Recorder, Paper Chart

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