BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NONIN MEDICAL, INC.

    Reg #: 2183646 · FEI: 2183646 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    72
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    NONIN MEDICAL, INC.
    Registration Number
    2183646
    FEI Number
    2183646
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    13700 1ST AVE, NORTH
    City
    Plymouth
    State
    MN
    ZIP
    55441
    Country
    US

    Regulatory Submissions

    510(k) Number
    K040589

    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
    Medical Device Data System OUG
    Oximeter, Wellness PGJ
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Oximeter, Tissue Saturation MUD
    Oximeter, Ear DPZ
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    Model 9600 Model 9700 nVision Data Management Nonin Connect App eVision Model 3245 8100SL X-100SP X-100M SenSmart Equanox 8100SS 8100SM X-100 X-100Hub INT-100 Onyx Vantage 9590 Model 9847 Model 9843 Model 3100 Model 8000A(X)-WO Model 8000A(X)-WO2 Model 3150 Model 3230 Model 3231 Model 3240 Regional Oximetry Sensor Sensor, 6500 Series 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, 8500 Series Sensors, 8000 Soft Series FILTER MOISTURE TRAP PulseSense LifeSense RespSense Model 4100 3231 Pulse Oximeter Model 4000 8000Q2 Model 7500 Model 8000J Series Model 8000A(X) Series Avant Model 2120 8000FC Sensor 8000FI Sensor Model 7500FO Model 9570 Model 9571 Model 9550, Onyx II Model 9590 Onyx Vantage Model 9560 H500 CO-Pilot Wireless Handheld Multi-Parameter System Model 9500 Oximetry 2500B 2500 2500C 7600PA Model 7600 Regional Oximeter System EQUANOX Model 8004CB Model 8004CB-NA Model 8003CA Model 8004CA 8000R 2500A Sensor, 7000 Series Sensor, 6000 Series

    Establishment Types

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