BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Spire Remote Patient Monitoring System

    Reg #: 3011166598 · FEI: 3011166598 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Wellinks
    Registration Number
    3011166598
    FEI Number
    3011166598
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    85 Willow St
    City
    New Haven
    State
    CT
    ZIP
    06511
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192952

    Owner / Operator

    Firm Name
    Wellinks
    Operator Number
    10085671
    Address
    85 Willow Street
    City
    New Haven
    State
    CT
    Postal Code
    06511
    Country
    US
    Correspondent
    Amy Aquilino

    Products

    Device Name Product Code
    System, Network And Communication, Physiological Monitors MSX

    Proprietary Names

    Spire Remote Patient Monitoring System Spire Health Remote Patient Monitoring System

    Establishment Types

    Manufacture Medical Device