BEUDAMED
    FDA Registration Active 🇺🇸 United States

    989803177981 Microstream® EtCO2 Consumables Smart CapnoLine® H O2 Pediatric Long

    Reg #: 3016618143 · FEI: 3016618143 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Philips North America LLC
    Registration Number
    3016618143
    FEI Number
    3016618143
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    222 Jacobs Street
    City
    Cambridge
    State
    MA
    ZIP
    02141
    Country
    US

    Regulatory Submissions

    510(k) Number
    K011536

    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

    989803177981 Microstream® EtCO2 Consumables Smart CapnoLine® H O2 Pediatric Long 989803177961 Microstream® EtCO2 Consumables Smart CapnoLine® H 02 Adult Long 989803160271 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Long 989803182981 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Long,Adult 989803177971 Microstream® EtCO2 Consumables Smart CapnoLine® H 02 Pediatric 989803182971 Microstream® EtCO2 Consumables Smart CapnoLine® H O2 Adult 989803177951 Microstream® EtCO2 Consumables Smart CapnoLine® H O2 Adult 989803182961 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Adult 989803182951 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Pediatric

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198