BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FloTrak Elite Module wI Capnostat 5 C02 Sensor

    Reg #: 1219324 · FEI: 1219324 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    RESPIRONICS NOVAMETRIX, LLC
    Registration Number
    1219324
    FEI Number
    1219324
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3000 Minuteman Rd.
    City
    Andover
    State
    MA
    ZIP
    01810
    Country
    US

    Regulatory Submissions

    510(k) Number
    K092217

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    1217116
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    Products

    Device Name Product Code
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Spirometer, Monitoring (W/Wo Alarm) BZK

    Proprietary Names

    FloTrak Elite Module wI Capnostat 5 C02 Sensor

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility