BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Utopia AV

    Reg #: 3004748541 · FEI: 3004748541 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Salter Labs
    Registration Number
    3004748541
    FEI Number
    3004748541
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    30 Spur Drive
    City
    El Paso
    State
    TX
    ZIP
    79906
    Country
    US

    Regulatory Submissions

    510(k) Number
    K052249

    Owner / Operator

    Firm Name
    SunMed
    Operator Number
    9038422
    Address
    2710 Northridge Drive NW, Suite A
    City
    Grand Rapids
    State
    MI
    Postal Code
    49544
    Country
    US
    Correspondent
    Rob Yamashita

    Products

    Device Name Product Code
    Ventilator, Non-Continuous (Respirator) BZD

    Proprietary Names

    Utopia AV

    Establishment Types

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