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

    G3000 OR AG2000; DISPOSABLE RESTING ELECTRODE

    K Number: K955815 · Decision Jul 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    328
    Applicant Total
    4
    Review Days
    210

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    Basic Information

    Device Name
    G3000 OR AG2000; DISPOSABLE RESTING ELECTRODE
    K Number
    K955815
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cmc Sense-It, Inc.
    Date Received
    December 26, 1995
    Decision Date
    July 23, 1996
    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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    Other Clearances by Cmc Sense-It, Inc.

    K Number Device Name
    K970603 D SERIES ELECTRODE
    K963159 CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES
    K955800 SI2000 (SENSE-IT TRADEMARK) OR G2000; DISPOSABLE RESTING ELECTRODE