BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Isolette 8000 plus Infant Incubator

    Reg #: 2510954 · FEI: 2510954 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DRAEGER MEDICAL SYSTEMS, INC.
    Registration Number
    2510954
    FEI Number
    2510954
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3135 QUARRY RD.
    City
    Telford
    State
    PA
    ZIP
    18969
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172154

    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
    Incubator, Neonatal FMZ

    Proprietary Names

    Isolette 8000 plus Infant Incubator

    Establishment Types

    Manufacture Medical Device