BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INTELLIVUE MX40 PATIENT MONITOR

    Reg #: 3012528160 · FEI: 3012528160 · 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
    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
    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

    Manufacture Medical Device for Another Party (Contract Manufacturer)