BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MyCardia AT

    Reg #: 2028530 · FEI: 1000125122 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Datrix LLC
    Registration Number
    2028530
    FEI Number
    1000125122
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    340 State Pl
    City
    Escondido
    State
    CA
    ZIP
    92029
    Country
    US

    Regulatory Submissions

    510(k) Number
    K112601

    Owner / Operator

    Firm Name
    Datrix LLC
    Operator Number
    10054495
    Address
    340 State pl.
    City
    Escondido
    State
    CA
    Postal Code
    92029
    Country
    US
    Correspondent
    Jon Barron

    Products

    Device Name Product Code
    Electrocardiograph, Ambulatory (Without Analysis) MWJ

    Proprietary Names

    MyCardia AT GEMS Sirona Lifesense mini Sentinel Sirona

    Establishment Types

    Manufacture Medical Device Remanufacture Medical Device Complaint File Establishment per 21 CFR 820.198