BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IntelliVue Patient Monitors

    Reg #: 1219324 · FEI: 1219324 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    RESPIRONICS NOVAMETRIX, LLC
    Registration Number
    1219324
    FEI Number
    1219324
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3000 Minuteman Rd.
    City
    Andover
    State
    MA
    ZIP
    01810
    Country
    US

    Regulatory Submissions

    510(k) Number
    K060221

    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 Patient Monitors Philips Sample Line W HUMID Kit, M2777A Philips PED Oral Nas CO2 O2 Can, M2761A CO2 Nasal Cannula - Pediatric Philips ADU Oral Nas CO2 O2 Can, M2760A Philips ADU PED Airway Adapter, M2768A Philips ADU Nasal CO2 Cannula, M2744A Philips ADU Nasal CO2 O2 Cannula, M2750A Philips PED INF Airway Adapter Philips ADU PED A ADPTR W Humid, M2772A Philips INF Nasal CO2 O2 Cannula CO2 Nasal Cannula - Infant Philips Sample Line Kit, M2776A Philips PED Oral Nasal CO2 Can, M2757A Philips PED INF A ADPTR W HUMID, M2773A Philips PED Nasal CO2 O2 Cannula, M2751A Philips ADU Oral Nasal CO2 Can, M2756A

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility