BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cura Bluetooth Blood Pressure Monitor

    Reg #: 3010560653 · FEI: 3010560653 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Omnia Medical
    Registration Number
    3010560653
    FEI Number
    3010560653
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6 Canyon Rd
    City
    MORGANTOWN
    State
    WV
    ZIP
    26508
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123669

    Owner / Operator

    Firm Name
    Omnia Medical
    Operator Number
    10045103
    Address
    6 Canyon Road, Suite 300
    City
    Morgantown
    State
    WV
    Postal Code
    26508
    Country
    US

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    Cura Bluetooth Blood Pressure Monitor

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198