BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    FlexTEMP System, Sensor - 989803178171

    Reg #: 3000126629 · FEI: 3000126629 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Philips Electronics Ltd
    Registration Number
    3000126629
    FEI Number
    3000126629
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1875 Buckhorn Gate, 5th Floor
    City
    Mississauga Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K152330

    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
    Shaylee Masilunas
    Address
    6501 Living Place
    City
    Pittsburgh
    State
    PA
    ZIP
    15206
    Country
    US
    Email
    [email protected]
    Phone
    724 8162019

    Products

    Device Name Product Code
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI

    Proprietary Names

    FlexTEMP System, Sensor - 989803178171 Expression MR ECG Leads, AAMI, Neonatal - 989803193741 Expression MR Wireless ECG Patient Module (Gen 3) 1-5 - 989803192761 Expression MR ECG Leads, IEC, CV - 989803193751 Expression MR400 MRI Patient Monitoring System (Model MR400) Expression MR Wireless SPO2 Patient module (Gen 3) 1-5 - 989803192771 Expression MR ECG Leads, IEC, Neonatal - 989803193771 Expression MR IBP Transducer Cable, 5ft - 989803194601 Expression MR ECG Leads, AAMI - 989803193721 Expression MR ECG Leads, IEC, Standard - 989803193761 Expression MR ECG Leads, AAMI, Standard - 989803193731 Expression MR Wireless ECG Patient Module (Gen 3) 6-10 - 989803194341 Expression MR FlexTEMP II Sensor - 989803194511 Expression MR Wireless SpO2 Patient Module (Gen 3)6-10 - 989803194331 Expression MR Universal Gating Interface - 989803195521 Expression MR400 New MRI Monitor Accessories - 866428

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device