BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Quantum Ventilation Module

    Reg #: 3006126428 · FEI: 3006126428 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SPECTRUM MEDICAL INC
    Registration Number
    3006126428
    FEI Number
    3006126428
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    481 Munn Road, Suite 180
    City
    Fort Mill
    State
    SC
    ZIP
    29715
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181942

    Owner / Operator

    Firm Name
    SPECTRUM MEDICAL INC
    Operator Number
    10025922
    Address
    481 Munn Road, Suite 180
    City
    Fort Mill
    State
    SC
    Postal Code
    29715
    Country
    US
    Correspondent
    Asia Lukuc

    Products

    Device Name Product Code
    Gas Control Unit, Cardiopulmonary Bypass DTX

    Proprietary Names

    Quantum Ventilation Module

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility