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

    NIIC MODEL: DX901 ASPIRATION SYSTEM

    K Number: K900185 · Decision May 24, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    27
    Applicant Total
    16
    Review Days
    128

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    Basic Information

    Device Name
    NIIC MODEL: DX901 ASPIRATION SYSTEM
    K Number
    K900185
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Niic U.S.A., Inc.
    Date Received
    January 16, 1990
    Decision Date
    May 24, 1990
    Product Code
    JFL
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JFL Ph Rate Measurement, Carbon-Dioxide

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