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

    OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044

    K Number: K061730 · Decision Aug 4, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    88
    Applicant Total
    2
    Review Days
    45

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    Basic Information

    Device Name
    OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044
    K Number
    K061730
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1600
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osmetech, Inc.
    Date Received
    June 20, 2006
    Decision Date
    August 4, 2006
    Product Code
    CEM
    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
    CEM Electrode, Ion Specific, Potassium

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