BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System

    K Number: K240640 · Decision Oct 8, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    178
    Same Product Code
    506
    Applicant Total
    1
    Review Days
    216

    Basic Information

    Device Name
    Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System
    K Number
    K240640
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sejoy Biomedical Co., Ltd
    Date Received
    March 6, 2024
    Decision Date
    October 8, 2024
    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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