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

    MODEL MC6500 ELECTROCARDIOGRAPH

    K Number: K895961 · Decision Jan 4, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    193
    Applicant Total
    8
    Review Days
    86

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    Basic Information

    Device Name
    MODEL MC6500 ELECTROCARDIOGRAPH
    K Number
    K895961
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cambridge Medical Instruments, Inc.
    Date Received
    October 10, 1989
    Decision Date
    January 4, 1990
    Product Code
    DSH
    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
    DSH Recorder, Magnetic Tape, Medical

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