BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Nellcor Bedside SpO2 Patient Monitoring System (PM100N)

    Reg #: 3003591740 · FEI: 3003591740 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDIANA CO., LTD.
    Registration Number
    3003591740
    FEI Number
    3003591740
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    132, Donghwagongdan-ro, Munmak-eup
    City
    Wonju-Si, Gangwon-do
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K142865

    Owner / Operator

    Firm Name
    MEDIANA CO., LTD.
    Operator Number
    9048468
    Address
    132, Donghwagongdan-ro, Munmak-eup
    City
    Wonju-Si, Gangwon-do
    State
    KR-NOTA
    Postal Code
    26365
    Country
    KR

    US Agent

    Business Name
    IRC USA
    Contact Name
    CHARLES MACK
    Address
    2950 E Lindrick Dr.
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938 ext. 0

    Products

    Device Name Product Code
    Oximeter DQA

    Proprietary Names

    Nellcor Bedside SpO2 Patient Monitoring System (PM100N)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)