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

    Microwave Therapeutic System

    K Number: K201262 · Decision Jul 9, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    67
    Applicant Total
    2
    Review Days
    424

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    Basic Information

    Device Name
    Microwave Therapeutic System
    K Number
    K201262
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanjing Eco Microwave System Co., Ltd.
    Date Received
    May 11, 2020
    Decision Date
    July 9, 2021
    Product Code
    NEY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NEY System, Ablation, Microwave And Accessories

    Similar 510(k) Clearances

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    Other Clearances by Nanjing Eco Microwave System Co., Ltd.

    K Number Device Name
    K201265 Disposable Microwave Therapeutic Antennas