BEUDAMED
    FDA Registration Active 🇺🇸 United States

    989803204601 Microstream™ Advance Pediatric Nasal CO2 Filter Line

    Reg #: 1218950 · FEI: 1218950 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    23
    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
    K181624

    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

    989803204601 Microstream™ Advance Pediatric Nasal CO2 Filter Line 989803204391 Microstream™ Advance Adult Oral-Nasal CO2 Filter Line 989803204361 Microstream™ Advance Adult Oral-Nasal CO2 Filter Line 989803204441 Microstream™ Advance Neonatal-Infant Nasal CO2 Filter Line 989803204351 Microstream™ Advance Pediatric Oral-Nasal CO2 Filter Line 989803204561 Microstream™ Advance Pediatric Oral-Nasal CO2 Filter Line 989803204581 Microstream™ Advance Adult Nasal CO2 Filter Line 989803204541 Microstream™ Advance Pediatric Oral-Nasal CO2 Filter Line 989803204621 Microstream™ Advance Adult Nasal CO2 Filter Line 989803204631 Microstream™ Advance Neonatal-Infant Nasal CO2 Filter Line 989803204481 Microstream™ Advance Adult Nasal CO2 Filter Line 989803204591 Microstream™ Advance Pediatric Nasal CO2 Filter Line 989803204431 Microstream™ Advance Neonatal-Infant Nasal CO2 Filter Line 989803204501 Microstream™ Advance Pediatric Nasal CO2 Filter Line 989803204571 Microstream™ Advance Adult Oral-Nasal CO2 Filter Line 989803204411 Microstream™ Advance Pediatric Oral-Nasal CO2 Filter Line 989803204421 Microstream™ Advance Neonatal-Infant Nasal CO2 Filter Line 989803204551 Microstream™ Advance Adult Oral-Nasal CO2 Filter Line 989803204611 Microstream™ Advance Adult Nasal CO2 Filter Line 989803204491 Microstream™ Advance Adult Nasal CO2 Filter Line 989803204381 Microstream™ Advance Adult Oral-Nasal CO2 Filter Line 989803204401 Microstream™ Advance Pediatric Oral-Nasal CO2 Filter Line 989803204371 Microstream™ Advance Adult Oral-Nasal CO2 Filter Line

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198