BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SOTERA WIRELESS

    Reg #: 3009673645 · FEI: 3009673645 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    11

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    Registration Details

    Registration Name
    SOTERA WIRELESS
    Registration Number
    3009673645
    FEI Number
    3009673645
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5841 Edison Place, Suite #140
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K122645

    Owner / Operator

    Firm Name
    Sotera Wireless, Inc.
    Operator Number
    10040989
    Address
    5841 Edison Place, Suite #140
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US
    Correspondent
    Andrew Nguyen

    Products

    Device Name Product Code
    Oximeter, Tissue Saturation MUD
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Oximeter DQA
    Continuous Measurement Thermometer FLL
    Detector And Alarm, Arrhythmia DSI
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    System, Network And Communication, Physiological Monitors MSX
    Tape And Bandage, Adhesive KGX
    Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling CBZ

    Proprietary Names

    Sotera Visi mobile monitoring system

    Establishment Types

    Manufacture Medical Device