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

    WR3500 AND WR3600 SERIES RECORDERS

    K Number: K894922 · Decision Jan 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    86
    Applicant Total
    1
    Review Days
    177

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    Basic Information

    Device Name
    WR3500 AND WR3600 SERIES RECORDERS
    K Number
    K894922
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.2810
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Western Graphtec
    Date Received
    August 2, 1989
    Decision Date
    January 26, 1990
    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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