BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EleGARD

    Reg #: 3012191403 · FEI: 3012191403 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Resuscitation Innovations LLC dba AdvancedCPR Solutions
    Registration Number
    3012191403
    FEI Number
    3012191403
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5201 Eden Avenue, Suite 300
    City
    Edina
    State
    MN
    ZIP
    55436
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221901

    Owner / Operator

    Firm Name
    Resuscitation Innovations LLC
    Operator Number
    10050254
    Address
    5201 Eden Avenue, Suite 300
    City
    Edina
    State
    MN
    Postal Code
    55436
    Country
    US

    Products

    Device Name Product Code
    Board, Cardiopulmonary FOA

    Proprietary Names

    EleGARD

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility