BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SmartLinx Vitals Plus Patient Monitoring System

    Reg #: 3012251275 · FEI: 3012251275 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    Flash Global
    Registration Number
    3012251275
    FEI Number
    3012251275
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5653 Creekside Pkwy
    City
    Lockbourne
    State
    OH
    ZIP
    43137
    Country
    US

    Regulatory Submissions

    510(k) Number
    K151071

    Owner / Operator

    Firm Name
    Flash Global
    Operator Number
    10051121
    Address
    5653 Creekside Parkway
    City
    Lockbourne
    State
    OH
    Postal Code
    43137
    Country
    US

    Products

    Device Name Product Code
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI

    Proprietary Names

    SmartLinx Vitals Plus Patient Monitoring System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device Manufacture Medical Device Remanufacture Medical Device