BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Optis Mobile Next Imaging System

    Reg #: 3009600098 · FEI: 3009600098 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Abbott Medical
    Registration Number
    3009600098
    FEI Number
    3009600098
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4 Robbins Rd
    City
    Westford
    State
    MA
    ZIP
    01886
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210458

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Computer, Blood-Pressure DSK
    Computer, Diagnostic, Programmable DQK
    System, Imaging, Optical Coherence Tomography (Oct) NQQ

    Proprietary Names

    Optis Mobile Next Imaging System OPTIS Mobile Next Ultreon 2 Software Upgrade Kit Optis Integrated Next Optis Integrated Pre-Install Kit Optis Tableside Controller Next Optis Next Upgrade Kit Optis Mobile Next Direct Upgrade Accessory Kit

    Establishment Types

    Manufacture Medical Device