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

    VER-MED A10017 UNIVERSAL ELECTRODE

    K Number: K905489 · Decision Mar 21, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    328
    Applicant Total
    9
    Review Days
    104

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    Basic Information

    Device Name
    VER-MED A10017 UNIVERSAL ELECTRODE
    K Number
    K905489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Vermont Medical, Inc.
    Date Received
    December 7, 1990
    Decision Date
    March 21, 1991
    Product Code
    DRX
    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
    DRX Electrode, Electrocardiograph

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    K921498 VER MED A10011 PNS DUAL ELEMENT ELECTRODE
    K915831 THERMAL PROBE COVER
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    K910139 VER-MED A10014 RESTING EKG ELECTRODE & A10021
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