BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SOBERLINK HEALTHCARE LLC

    Reg #: 3013019743 · FEI: 3013019743 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    SOBERLINK HEALTHCARE LLC
    Registration Number
    3013019743
    FEI Number
    3013019743
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7711 Center Avenue, #400
    City
    Huntington Beach
    State
    CA
    ZIP
    92647
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160613

    Owner / Operator

    Firm Name
    Soberlink Healthcare LLC
    Operator Number
    10052354
    Address
    7711 Center Avenue, #400
    City
    Huntington Beach
    State
    CA
    Postal Code
    92647
    Country
    US
    Correspondent
    Brad Keays

    Products

    Device Name Product Code
    Devices, Breath Trapping, Alcohol DJZ

    Proprietary Names

    Soberlink Cellular Device and Sober Sky Web Portal

    Establishment Types

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