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

    Rotatable Connector (5944RL)

    K Number: K241199 · Decision Jan 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    128
    Applicant Total
    2
    Review Days
    268

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    Basic Information

    Device Name
    Rotatable Connector (5944RL)
    K Number
    K241199
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Launch Electrical Co., Ltd.
    Date Received
    April 30, 2024
    Decision Date
    January 23, 2025
    Product Code
    LDF
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LDF Electrode, Pacemaker, Temporary

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    Other Clearances by Shenzhen Launch Electrical Co., Ltd.

    K Number Device Name
    K181967 Disposable Temperature Probe