BEUDAMED
    FDA Registration Active 🇺🇸 United States

    989803204451 Microstream™ Advance Adult-Intermediate Bite Block CO2 Filter Line

    Reg #: 3016618143 · FEI: 3016618143 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    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
    K093388

    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

    989803204451 Microstream™ Advance Adult-Intermediate Bite Block CO2 Filter Line 989803204461 Microstream™ Advance Adult-Intermediate Bite Block CO2 Filter Line 989803204471 Microstream™ Advance Adult-Intermediate Bite Block CO2 Filter Line 989803178041 Microstream® EtCO2 Consumables Smart CapnoLine® Guard O2 989803182991 Microstream® EtCO2 Consumables Smart CapnoLine® Guard O2 989803178031 Microstream® EtCO2 Consumables Smart CapnoLine® Guard 989803178051 Microstream® EtCO2 Consumables Smart CapnoLine® Guard O2 Long 989803183001 Microstream® EtCO2 Consumables Smart CapnoLine® Guard O2 Long

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198