BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EEG Infinity Pod

    Reg #: 3005783425 · FEI: 3005783425 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    DRAEGER MEDICAL SYSTEMS, INC.
    Registration Number
    3005783425
    FEI Number
    3005783425
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6 TECH DRIVE
    City
    ANDOVER
    State
    MA
    ZIP
    01810
    Country
    US

    Regulatory Submissions

    510(k) Number
    K991012

    Owner / Operator

    Firm Name
    Draeger Medical Systems, Inc.
    Operator Number
    9070398
    Address
    6 Tech Drive
    City
    Andover
    State
    MA
    Postal Code
    01810
    Country
    US

    Products

    Device Name Product Code
    Reduced- Montage Standard Electroencephalograph OMC
    Burst Suppression Detection Software For Electroencephalograph ORT
    Non-Normalizing Quantitative Electroencephalograph Software OLT

    Proprietary Names

    EEG Infinity Pod

    Establishment Types

    Manufacture Medical Device