BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SpO2 Sensor Wrap

    Reg #: 3010824458 · FEI: 3010824458 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FABRITEQ
    Registration Number
    3010824458
    FEI Number
    3010824458
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11220 Gilbert Dr
    City
    Knoxville
    State
    TN
    ZIP
    37932
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172200

    Owner / Operator

    Firm Name
    FabriTEQ
    Operator Number
    10046621
    Address
    11220 Gilbert Dr
    City
    Knoxville
    State
    TN
    Postal Code
    37932
    Country
    US
    Correspondent
    David E Dewitt

    Products

    Device Name Product Code
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI

    Proprietary Names

    SpO2 Sensor Wrap

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)