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

    ECG INTERFERENCE FILTER TF-03

    K Number: K832888 · Decision Jan 18, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    5
    Review Days
    145

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    Basic Information

    Device Name
    ECG INTERFERENCE FILTER TF-03
    K Number
    K832888
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    La Jolla Technology, Inc.
    Date Received
    August 26, 1983
    Decision Date
    January 18, 1984
    Product Code
    DPS
    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
    DPS Electrocardiograph

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