BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    989803203051 SedLine Measurement Device

    Reg #: 9610816 · FEI: 3002807167 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Philips Medizin Systeme Boeblingen GmbH
    Registration Number
    9610816
    FEI Number
    3002807167
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    HEWLETT-PACKARD STRASSE 2
    City
    BOEBLINGEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K221348

    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

    US Agent

    Business Name
    Philips
    Contact Name
    Deborah Currlin
    Address
    222 Jacobs Street
    City
    Cambridge
    State
    MA
    ZIP
    02141
    Country
    US
    Email
    [email protected]
    Phone
    858 9452753

    Products

    Device Name Product Code
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX

    Proprietary Names

    989803203051 SedLine Measurement Device 989803203041 IRMA CO2 Measurement Device 989803203031 ISA CO2 Measurement Device 867185 PHILIPS Masimo CO2 Module 867184 PHILIPS Masimo O3 Module 867186 PHILIPS Masimo SedLine Module 989803203021 Masimo O3 Measurement Device

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device