BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ViSi Mobile Monitoring System

    Reg #: 3009673645 · FEI: 3009673645 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SOTERA WIRELESS
    Registration Number
    3009673645
    FEI Number
    3009673645
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5841 Edison Place, Suite #140
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141496

    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
    Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling CBZ

    Proprietary Names

    ViSi Mobile Monitoring System

    Establishment Types

    Manufacture Medical Device