BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Paceart Optima System 1.6 with Analytics

    Reg #: 2182208 · FEI: 2182208 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    MEDTRONIC, INC.
    Registration Number
    2182208
    FEI Number
    2182208
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8200 Coral Sea Street NE
    City
    Mounds View
    State
    MN
    ZIP
    55112
    Country
    US

    Regulatory Submissions

    510(k) Number
    K110693

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

    Device Name Product Code
    Analyzer, Pacemaker Generator Function, Indirect KRE
    Electrocardiograph DPS
    Medical Device Data System OUG
    Transmitters And Receivers, Electrocardiograph, Telephone DXH

    Proprietary Names

    Paceart Optima System 1.6 with Analytics Paceart Optima Paceart Optima System 1.7 Paceart Optima System 1.8

    Establishment Types

    Manufacture Medical Device