BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    Analyzer

    Reg #: 3004415070 · FEI: 3004415070 · Expires 2025
    View on FDA
    Products
    10
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    10

    Registration Details

    Registration Name
    KB Components Finland Oy
    Registration Number
    3004415070
    FEI Number
    3004415070
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ilvestie 5
    City
    Nurmijarvi Etela-Karjala
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K051092

    Owner / Operator

    Firm Name
    KB Components Finland Oy
    Operator Number
    10032433
    Address
    Ilvestie 5
    City
    Nurmijarvi
    State
    FI-NOTA
    Postal Code
    01900
    Country
    FI
    Correspondent
    Mindy McCann

    US Agent

    Business Name
    Qserve Group US, Inc.
    Contact Name
    Mindy McCann
    Address
    350 S Main Street, Suite 309
    City
    Doylestown
    State
    PA
    ZIP
    18901
    Country
    US
    Email
    [email protected]
    Phone
    424 2718169

    Products

    Device Name Product Code
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Computer, Oxygen-Uptake BZL
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Spirometer, Monitoring (W/Wo Alarm) BZK
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ

    Proprietary Names

    Analyzer

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)