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

    MICRO CO2 APPARATUS

    K Number: K880967 · Decision Apr 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    5
    Review Days
    51

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    Basic Information

    Device Name
    MICRO CO2 APPARATUS
    K Number
    K880967
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Hf Scientific, Inc.
    Date Received
    March 8, 1988
    Decision Date
    April 28, 1988
    Product Code
    CIE
    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
    CIE Volumetric/Manometric, Carbon-Dioxide

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