BEUDAMED
    FDA Registration Active 🇨🇳 China

    Finger Pulse Oximeter Model: X1906P,X1805,X1805P,X1906,X1907,X1907P,X1908,X1908P,X1909,X1909P

    Reg #: 3009617411 · FEI: 3009617411 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
    Registration Number
    3009617411
    FEI Number
    3009617411
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    101, Building 1, No.15 Xiusheng 2nd Road, Xiuxin Community, Kengzi Street, Pingshan District,
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K221798

    Owner / Operator

    Firm Name
    Shenzhen Changkun Technology Co., Ltd.
    Operator Number
    10071297
    Address
    101, Building 1, No.15 Xiusheng 2nd Road, Xiuxin Community, Kengzi Street, Pingshan District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518118
    Country
    CN
    Correspondent
    Qingpeng Wang

    Products

    Device Name Product Code
    Oximeter DQA

    Proprietary Names

    Finger Pulse Oximeter Model: X1906P,X1805,X1805P,X1906,X1907,X1907P,X1908,X1908P,X1909,X1909P

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198