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

    SWITCHING UNIT ELECTRODE CATHETER

    K Number: K834602 · Decision May 9, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    184
    Applicant Total
    5
    Review Days
    131

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    Basic Information

    Device Name
    SWITCHING UNIT ELECTRODE CATHETER
    K Number
    K834602
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Webster Laboratories, Inc.
    Date Received
    December 30, 1983
    Decision Date
    May 9, 1984
    Product Code
    DRF
    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
    DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

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    Other Clearances by Webster Laboratories, Inc.

    K Number Device Name
    K853383 CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN
    K841802 ELECTRODE CATHETER, ORTHOGONAL TYPE
    K823361 SWITCHING UNIT ELECTRODE CATHETERS
    K813271 TEMPERATURE PROBES