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

    SYSTEM II

    K Number: K771372 · Decision Aug 4, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    86
    Applicant Total
    10
    Review Days
    10

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    Basic Information

    Device Name
    SYSTEM II
    K Number
    K771372
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.2810
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Irex Corp.
    Date Received
    July 25, 1977
    Decision Date
    August 4, 1977
    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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