BEUDAMED
    FDA Registration Active 🇨🇳 China

    Disposable SpO2 Sensor (model: SP1319, SP1319A, SP1219, SP1219A, SP1019, SP1019A, SP1002, SP1003, SP1015A)

    Reg #: 3015616170 · FEI: 3015616170 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHENZHEN SINO-K MEDICAL TECHNOLOGY CO., LTD.
    Registration Number
    3015616170
    FEI Number
    3015616170
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4th Floor, Building 2, West Side of Xixiang Veterans Industry City, Gongle Community, Xixiang Street, Baoan District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K192608

    Owner / Operator

    Firm Name
    Shenzhen SINO-K Medical Technology Co., Ltd.
    Operator Number
    10084033
    Address
    4th Floor, Building 2, West Side of Xixiang Veterans Industry City, Gongle Community, Xixiang Street, Baoan District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518101
    Country
    CN

    US Agent

    Business Name
    Dynasty Medical Consulting Inc.
    Contact Name
    Linda Chen
    Address
    302 Round Lake Dr
    City
    Rosenberg
    State
    TX
    ZIP
    77469
    Country
    US
    Email
    [email protected]
    Phone
    832 3809688

    Products

    Device Name Product Code
    Oximeter DQA

    Proprietary Names

    Disposable SpO2 Sensor (model: SP1319, SP1319A, SP1219, SP1219A, SP1019, SP1019A, SP1002, SP1003, SP1015A) Disposable SpO2 Sensor (model: SP1119, SP1119A)

    Establishment Types

    Manufacture Medical Device