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

    MODEL MICRO FD+ AMBULATORY ECG MONITOR

    K Number: K872508 · Decision Sep 25, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    190
    Applicant Total
    14
    Review Days
    93

    Basic Information

    Device Name
    MODEL MICRO FD+ AMBULATORY ECG MONITOR
    K Number
    K872508
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    ADVANCED MEDICAL PRODUCTS, INC.
    Date Received
    June 24, 1987
    Decision Date
    September 25, 1987
    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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