BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INTELLIVUE MX40 PATIENT MONITOR

    Reg #: 3016618143 · FEI: 3016618143 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    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
    K103646

    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(With Arrhythmia Detection Or Alarms) MHX

    Proprietary Names

    INTELLIVUE MX40 PATIENT MONITOR 989803199081 MX40 Adapter SpO2-only 989803171831 ECG 5 lead Grabber, AAMI, Tele 989803199091 MX40 Adapter 5L+SpO2 989803171811 ECG 3 lead Grabber, AAMI + SpO2, Tele 989803171951 ECG 5 lead Grabber, IEC + SpO2, Tele 989803171861 ECG 6 lead Grabber, AAMI, Tele 989803171841 ECG 5 lead Snaps, AAMI + SpO2, Tele 989803171821 ECG 5 lead Snaps, AAMI, Tele 989803171931 ECG 5 lead Grabber, IEC, Tele 989803171911 ECG 3 lead Grabber, IEC + SpO2, Tele 989803171971 CBL ECG 6 Lead Grabber, IEC+SpO2, Tele 989803171851 ECG 5 lead Grabber, AAMI + SpO2, Tele 989803199101 MX40 Adapter 3L+SpO2 989803171961 ECG 6 lead Grabber, IEC, Tele 989803199071 ECG 6 lead Grabber, IEC + SpO2, Tele 989803171871 CBL ECG 6lead Grabber, AAMI + SpO2, Tele

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility