BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sensor PAC

    Reg #: 2023374 · FEI: 2023374 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    DIVERSATEK HEALTHCARE INC.
    Registration Number
    2023374
    FEI Number
    2023374
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    9150 Commerce Center Cir Ste 500
    City
    Highlands Ranch
    State
    CO
    ZIP
    80129
    Country
    US

    Regulatory Submissions

    510(k) Number
    K012232

    Owner / Operator

    Firm Name
    DIVERSATEK HEALTHCARE
    Operator Number
    2023374
    Address
    9150 COMMERCE CENTER CIR.,#500, --
    City
    Highlands Ranch
    State
    CO
    Postal Code
    80129
    Country
    US
    Correspondent
    Laura L Boll

    Products

    Device Name Product Code
    System, Gastrointestinal Motility (Electrical) FFX

    Proprietary Names

    Sensor PAC Insight G3 Insight G2 Greenfield ZepHr Viscous Swallow Challenge

    Establishment Types

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