BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    CareSens S Fit BT Blood Glucose Monitoring System

    K Number: K193590 · Decision Jan 17, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    27
    Review Days
    25

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    Basic Information

    Device Name
    CareSens S Fit BT Blood Glucose Monitoring System
    K Number
    K193590
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    I-Sens, Inc.
    Date Received
    December 23, 2019
    Decision Date
    January 17, 2020
    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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