BEUDAMED
    FDA Registration Active 🇨🇳 China

    Pulse Oximeter; Pulse Oximeter FS10C and FS20C; Pulse Oximeter FS10D and FS20D

    Reg #: 3011353016 · FEI: 3011353016 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD.
    Registration Number
    3011353016
    FEI Number
    3011353016
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Accurate Industrial Park, No.108, Zhixian Road, Xuelian Community, Xueshi Street of Yuelu District
    City
    Changsha Hunan
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K141105

    Owner / Operator

    Firm Name
    Hunan Accurate Bio-Medical Technology Co., Ltd.
    Operator Number
    10048204
    Address
    Accurate Industrial Park, No.108, Zhixian Road, Xuelian Community, Xueshi Street of Yuelu District
    City
    Changsha
    State
    Hunan
    Postal Code
    410208
    Country
    CN
    Correspondent
    Li Zhang

    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

    Pulse Oximeter; Pulse Oximeter FS10C and FS20C; Pulse Oximeter FS10D and FS20D Pulse Oximeter FS10E and FS20E Pulse Oximeter FS10F and FS20F;Pulse Oximeter FS10I;Pulse Oximeter FS10K and FS20K;Pulse Oximeter FS10P; Pulse Oximeter (model: FS20P, FS10L, FS20L, FS10M, FS20M, FS20I)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device