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

    NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002

    K Number: K070255 · Decision Jun 13, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    89
    Review Days
    138

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    Basic Information

    Device Name
    NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002
    K Number
    K070255
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nova Biomedical Corp.
    Date Received
    January 26, 2007
    Decision Date
    June 13, 2007
    Product Code
    NBW
    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
    NBW System, Test, Blood Glucose, Over The Counter

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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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