BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System

    Reg #: 3031162043 · FEI: 3031162043 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PRECISION MONITORING, LLC.
    Registration Number
    3031162043
    FEI Number
    3031162043
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    820 SW Wilshire Blvd
    City
    Burleson
    State
    TX
    ZIP
    76028
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230265

    Owner / Operator

    Firm Name
    PRECISION MONITORING, LLC.
    Operator Number
    10090833
    Address
    820 SW Wilshire Blvd
    City
    Burleson
    State
    TX
    Postal Code
    76028
    Country
    US
    Correspondent
    Braden Cazares

    Products

    Device Name Product Code
    Detector And Alarm, Arrhythmia DSI

    Proprietary Names

    MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System

    Establishment Types

    Repack or Relabel Medical Device