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

    SKIN PREP ANALYZER

    K Number: K874327 · Decision Nov 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    10
    Applicant Total
    82
    Review Days
    33

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    Basic Information

    Device Name
    SKIN PREP ANALYZER
    K Number
    K874327
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2370
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Marquette Electronics, Inc.
    Date Received
    October 21, 1987
    Decision Date
    November 23, 1987
    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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