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

    IMPEDANCE/8200 MONITOR-MODEL 8300

    K Number: K840358 · Decision Oct 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    10
    Applicant Total
    24
    Review Days
    278

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    Basic Information

    Device Name
    IMPEDANCE/8200 MONITOR-MODEL 8300
    K Number
    K840358
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2370
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Aequitron Medical, Inc.
    Date Received
    January 26, 1984
    Decision Date
    October 30, 1984
    Product Code
    KRC
    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
    KRC Tester, Electrode, Surface, Electrocardiographic

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