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

    VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System

    K Number: K173140 · Decision Dec 19, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    2
    Review Days
    446

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    Basic Information

    Device Name
    VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System
    K Number
    K173140
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vivachek Laboratories, Inc.
    Date Received
    September 29, 2017
    Decision Date
    December 19, 2018
    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 Vivachek Laboratories, Inc.

    K Number Device Name
    K160179 VivaChek Ino Blood Glucose Monitoring System