BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    MEDICAL DISPLAY, MODELS MDM 1900-1NG AND MDM 1900-1NR

    K Number: K061303 · Decision May 25, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    2
    Review Days
    15

    Basic Information

    Device Name
    MEDICAL DISPLAY, MODELS MDM 1900-1NG AND MDM 1900-1NR
    K Number
    K061303
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CHILIN TECHNOLOGY CO. LTD
    Date Received
    May 10, 2006
    Decision Date
    May 25, 2006
    Product Code
    LLZ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    LLZ System, Image Processing, Radiological

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    Other Clearances by CHILIN TECHNOLOGY CO. LTD

    K Number Device Name
    K061305 MEDICAL DISPLAY, MDC1900-1LG (1LR)