BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Model 8101AA/8101AP Sensors, Model 8102AA/8102AP Sensors, Model 8100Q2 Sensor, Model 8101Q2 Sensor, Model 8102Q2 Sensor

    Reg #: 2183646 · FEI: 2183646 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    NONIN MEDICAL, INC.
    Registration Number
    2183646
    FEI Number
    2183646
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    13700 1ST AVE, NORTH
    City
    Plymouth
    State
    MN
    ZIP
    55441
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160865

    Owner / Operator

    Firm Name
    NONIN MEDICAL, INC.
    Operator Number
    2183646
    Address
    13700 1ST AVE, NORTH, --
    City
    Plymouth
    State
    MN
    Postal Code
    55441
    Country
    US
    Correspondent
    John Melquist

    Products

    Device Name Product Code
    Oximeter DQA
    Oximeter, Ear DPZ

    Proprietary Names

    Model 8101AA/8101AP Sensors, Model 8102AA/8102AP Sensors, Model 8100Q2 Sensor, Model 8101Q2 Sensor, Model 8102Q2 Sensor Model 6100C Series Sensors, Model 6101C Series Sensors, Model 6102C Series Sensors, Model 8100AA/8100AP Sensors,

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device