BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    IntelliVue NMT Hand Adapter

    Reg #: 9610816 · FEI: 3002807167 · Expires 2025
    View on FDA
    Products
    39
    Proprietary Names
    6
    Establishment Types
    3
    Classifications
    39

    Registration Details

    Registration Name
    Philips Medizin Systeme Boeblingen GmbH
    Registration Number
    9610816
    FEI Number
    3002807167
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    HEWLETT-PACKARD STRASSE 2
    City
    BOEBLINGEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K122439

    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
    Deborah Currlin
    Address
    222 Jacobs Street
    City
    Cambridge
    State
    MA
    ZIP
    02141
    Country
    US
    Email
    [email protected]
    Phone
    858 9452753

    Products

    Device Name Product Code
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Generator, Electroencephalograph Test Signal GWR
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    Electrocardiograph DPS
    Continuous Measurement Thermometer FLL
    Probe, Thermodilution KRB
    System, Signal Isolation DRJ
    Stimulator, Nerve, Peripheral, Electric KOI
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Recorder, Magnetic Tape, Medical DSH
    Oximeter DQA
    Plethysmograph, Impedance DSB
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    System, Network And Communication, Physiological Monitors MSX
    Detector And Alarm, Arrhythmia DSI
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Monitor, St Segment With Alarm MLD
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Monitor, St Segment MLC
    Recorder, Paper Chart DSF
    Adaptor, Lead Switching, Electrocardiograph DRW
    Transducer, Blood-Pressure, Extravascular DRS
    Tester, Electrode, Surface, Electrocardiographic KRC
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Calculator, Pulmonary Function Data BZC
    Analyzer, Spectrum, Electroencephalogram Signal GWS
    Computer, Blood-Pressure DSK
    Alarm, Blood-Pressure DSJ
    Monitor, Breathing Frequency BZQ
    Monitor, Carbon-Dioxide, Cutaneous LKD

    Proprietary Names

    IntelliVue NMT Hand Adapter IntelliVue X2 Multi-Measurement Module MP90 MX600 MX700 MX800 Intellivue Pat. Monitors Philips MP2 MP5 MP5TMP5SC MP20 MP30 MP40 MP50 MP60 MP70 MP80 NMT Patient Cable (989803174581) NMT Module (865383)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device