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

    NOVA CO-OXIMETER ANALYZER

    K Number: K955013 · Decision Apr 25, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    4
    Applicant Total
    89
    Review Days
    176

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    Basic Information

    Device Name
    NOVA CO-OXIMETER ANALYZER
    K Number
    K955013
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nova Biomedical Corp.
    Date Received
    November 1, 1995
    Decision Date
    April 25, 1996
    Product Code
    GLY
    Advisory Committee
    Hematology
    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
    GLY Oximeter To Measure Hemoglobin

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    K061830 STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+
    K060345 NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS
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