BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BLOOD GAS QUALITY CONTROL SOFT-86000F

    K Number: K831574 · Decision Oct 14, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    77
    Applicant Total
    1
    Review Days
    151

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    Basic Information

    Device Name
    BLOOD GAS QUALITY CONTROL SOFT-86000F
    K Number
    K831574
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2100
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Computermate, Inc.
    Date Received
    May 16, 1983
    Decision Date
    October 14, 1983
    Product Code
    JQP
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JQP Calculator/Data Processing Module, For Clinical Use

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