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

    SpO2 Extension Cable

    K Number: K242986 · Decision May 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    104
    Applicant Total
    2
    Review Days
    218

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    Basic Information

    Device Name
    SpO2 Extension Cable
    K Number
    K242986
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beijing Rongrui-Century Science & Technology Co., Ltd.
    Date Received
    September 26, 2024
    Decision Date
    May 2, 2025
    Product Code
    DSA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DSA Cable, Transducer And Electrode, Patient, (Including Connector)

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    Other Clearances by Beijing Rongrui-Century Science & Technology Co., Ltd.

    K Number Device Name
    K222370 SpO2 Extension Cable