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

    IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM

    K Number: K132180 · Decision Jun 25, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    3
    Review Days
    345

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    Basic Information

    Device Name
    IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM
    K Number
    K132180
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ideal Life, Inc.
    Date Received
    July 15, 2013
    Decision Date
    June 25, 2014
    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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    Other Clearances by Ideal Life, Inc.

    K Number Device Name
    K080538 IDEAL LIFE POD (MODEL ILP 0001)
    K060504 IDEAL LIFE BP-MANAGER, MODEL BPM 0001; IDEAL LIFE POD, MODEL ILP 0001