BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    D-lite+ Spirometry Kit 2m/7ft, 8004381

    Reg #: 9610105 · FEI: 3002806783 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    27
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    GE HEALTHCARE FINLAND OY
    Registration Number
    9610105
    FEI Number
    3002806783
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    KUORTANEENKATU 2
    City
    HELSINKI Uusimaa
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K211171

    Owner / Operator

    Firm Name
    GE HealthCare Technologies Inc.
    Operator Number
    9912004
    Address
    3000 N. Grandview Blvd
    City
    Waukesha
    State
    WI
    Postal Code
    53188
    Country
    US

    US Agent

    Business Name
    GE HealthCare Technologies, Inc
    Contact Name
    Tracey Holevas
    Address
    3000 N. Grandview BLVD
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US
    Email
    [email protected]
    Phone
    262 3092157

    Products

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

    Proprietary Names

    D-lite+ Spirometry Kit 2m/7ft, 8004381 Gas Sampling Line, Disposable, PVC/PE, 6m/20ft, 2097307-003 D-lite++ Patient Spirometry Set, 3m/10ft, 2104297-002 Gas Sampling Line, Disposable, PVC/PE, 2m/7ft, 2097307-001 E-sCO E-sCAiOV E-sCAiOVE E-sCOV E-sCAiOVX Pedi-lite+ Spirometry Kit 2m/7ft, 8002718 D-lite++ Patient Spirometry Set, 2m/7ft, 2104297-001 D-fend Pro Water Trap, M1182629 CARESCAPE Respiratory Modules SPIROMETRY TUBE, DISPOSABLE, 2M/7FT 890031 D-lite+ sensor, disposable, Adult, 896952 Pedi-lite+ sensor, disposable, Pediatric, 8001948 Gas Sampling Line, Disposable, PVC/PE, 3m/10ft, 2097307-002 E-sCAiO D-lite sensor, reusable, Adult, 733910-HEL D-Lite+ Spirometry Kit 3m/10ft, 8004382 E-sCAiOE E-sCOVX Pedi-lite sensor, reusable, Pediatric, 73393 Pedi-Lite+ Spirometry Kit 3m/10ft, M1032634 SPIROMETRY TUBE, DISPOSABLE, 3M/10FT 884101 D-fend Pro+ Water Trap, M1200227 SPIROMETRY TUBE, DISPOSABLE, 6M/20FT 891191-HEL

    Establishment Types

    Manufacture Medical Device