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

    Lifetech Cardio Temporary Pacemaker

    K Number: K232721 · Decision Jan 7, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    64
    Applicant Total
    2
    Review Days
    124

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    Basic Information

    Device Name
    Lifetech Cardio Temporary Pacemaker
    K Number
    K232721
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3600
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.
    Date Received
    September 5, 2023
    Decision Date
    January 7, 2024
    Product Code
    DTE
    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
    DTE Pulse-Generator, Pacemaker, External

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    Other Clearances by Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.

    K Number Device Name
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