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

    3M RED DOT 2330 RESTING EKG ELECTRODE

    K Number: K932454 · Decision Aug 16, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    328
    Applicant Total
    49
    Review Days
    87

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    Basic Information

    Device Name
    3M RED DOT 2330 RESTING EKG ELECTRODE
    K Number
    K932454
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3M Health Care, Ltd.
    Date Received
    May 21, 1993
    Decision Date
    August 16, 1993
    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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