BEUDAMED
    FDA Registration Active 🇺🇸 United States

    989803178001 Microstream® EtCO2 Consumables CapnoLine® H O2 Infant/ Neonatal

    Reg #: 1218950 · FEI: 1218950 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Philips North America LLC
    Registration Number
    1218950
    FEI Number
    1218950
    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
    K010024

    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

    Proprietary Names

    989803178001 Microstream® EtCO2 Consumables CapnoLine® H O2 Infant/ Neonatal 989803179101 Microstream® EtCO2 Consumables Nasal Filterline O2 Adult 989803179121 Microstream® EtCO2 Consumables Filterline O2 Pediatric 989803178021 Microstream® EtCO2 Consumables Nasal FilterLine Infant/Neonatal 989803183071 Microstream® EtCO2 Consumables CapnoLine® H O2 M4681A Microstream® EtCO2 Consumables CapnoLine® H O2 989803179111 Microstream® EtCO2 Consumables Nasal Filterline O2 Adult

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198