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

    Medical Endoscope Image Processing System

    K Number: K210270 · Decision Oct 1, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    170
    Applicant Total
    2
    Review Days
    242

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    Basic Information

    Device Name
    Medical Endoscope Image Processing System
    K Number
    K210270
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jiangsu Jiyuan Medical Technology Co., Ltd.
    Date Received
    February 1, 2021
    Decision Date
    October 1, 2021
    Product Code
    HIH
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HIH Hysteroscope (And Accessories)

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    Other Clearances by Jiangsu Jiyuan Medical Technology Co., Ltd.

    K Number Device Name
    K252793 ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)