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

    GEM-6, WITH COMPONENTS

    K Number: K854357 · Decision Jan 8, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    46
    Applicant Total
    1
    Review Days
    71

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    Basic Information

    Device Name
    GEM-6, WITH COMPONENTS
    K Number
    K854357
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Diamond Electro-Tech, Inc.
    Date Received
    October 29, 1985
    Decision Date
    January 8, 1986
    Product Code
    DRY
    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
    DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

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