BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FlexTEMP System, Sensor - 989803178171

    Reg #: 3012528160 · FEI: 3012528160 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Philips North America LLC
    Registration Number
    3012528160
    FEI Number
    3012528160
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1001 Murry Ridge Lane, STE A
    City
    Murrysville
    State
    PA
    ZIP
    15668
    Country
    US

    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

    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

    Manufacture Medical Device for Another Party (Contract Manufacturer)