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

    OptiScanner® 5000 Glucose Monitoring System

    K Number: K192785 · Decision Feb 5, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    128

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    Basic Information

    Device Name
    OptiScanner® 5000 Glucose Monitoring System
    K Number
    K192785
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Optiscan Biomedical Corporation
    Date Received
    September 30, 2019
    Decision Date
    February 5, 2020
    Product Code
    LZF
    Advisory Committee
    General Hospital
    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
    LZF Pump, Infusion, Analytical Sampling

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