BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Philips North America LLC

    Reg #: 3016701404 · FEI: 3016701404 · Expires 2026
    View on FDA
    Products
    59
    Proprietary Names
    171
    Establishment Types
    2
    Classifications
    59

    Registration Details

    Registration Name
    Philips North America LLC
    Registration Number
    3016701404
    FEI Number
    3016701404
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1003 Corporate Lane, STE B
    City
    Export
    State
    PA
    ZIP
    15632
    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
    Full-Montage Standard Electroencephalograph GWQ
    Monitor, Breathing Frequency BZQ
    Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK
    Computer, Blood-Pressure DSK
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Recorder, Paper Chart DSF
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Monitor, St Segment With Alarm MLD
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Alarm, Blood-Pressure DSJ
    Calculator, Pulmonary Function Data BZC
    Electrocardiograph DPS
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Continuous Measurement Thermometer FLL
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Oximeter DQA
    Stimulator, Nerve, Peripheral, Electric KOI
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Monitor, Carbon-Dioxide, Cutaneous LKD
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    System, Network And Communication, Physiological Monitors MSX
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Analyzer, Spectrum, Electroencephalogram Signal GWS
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Transducer, Blood-Pressure, Extravascular DRS
    Monitor, Uterine Contraction, External (For Use In Clinic) HFM
    System, Monitoring, Perinatal HGM
    Detector And Alarm, Arrhythmia DSI
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Transducer, Ultrasonic, Obstetric HGL
    Plethysmograph, Photoelectric, Pneumatic Or Hydraulic JOM
    Blood Pressure Cuff DXQ
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Transducer, Pressure, Intrauterine HFN
    Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia LPP
    Electrode, Electrocardiograph DRX
    Burst Suppression Detection Software For Electroencephalograph ORT
    Index-Generating Electroencephalograph Software OLW
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Reduced- Montage Standard Electroencephalograph OMC
    Generator, Electroencephalograph Test Signal GWR
    System, Signal Isolation DRJ
    Recorder, Magnetic Tape, Medical DSH
    Probe, Thermodilution KRB
    Plethysmograph, Impedance DSB
    Adaptor, Lead Switching, Electrocardiograph DRW
    Monitor, St Segment MLC
    Tester, Electrode, Surface, Electrocardiographic KRC
    Electrocardiograph, Ambulatory, With Analysis Algorithm MLO
    Medical Device Data System OUG
    Electrocardiograph, Ambulatory (Without Analysis) MWJ
    Display, Cathode-Ray Tube, Medical DXJ
    Computer, Diagnostic, Programmable DQK
    Cannula, Nasal, Oxygen CAT

    Proprietary Names

    IntelliVue 4-Slot Module Rack FMX-4 (866468) IntelliVue Patient Monitor MX850 (866470) IntelliVue Patient Monitor MX750 (866471) Expression MR ECG Leads, IEC, Neonatal - 989803193771 Expression MR ECG Leads, IEC, CV - 989803193751 Expression MR ECG Leads, AAMI, Neonatal - 989803193741 Expression MR Wireless SPO2 Patient module (Gen 3) 1-5 - 989803192771 Expression MR Universal Gating Interface - 989803195521 Expression MR400 MRI Patient Monitoring System (Model MR400) Expression MR Wireless ECG Patient Module (Gen 3) 6-10 - 989803194341 Expression MR ECG Leads, AAMI - 989803193721 Expression MR ECG Leads, AAMI, Standard - 989803193731 Expression MR ECG Leads, IEC, Standard - 989803193761 FlexTEMP System, Sensor - 989803178171 Expression MR Wireless ECG Patient Module (Gen 3) 1-5 - 989803192761 Expression MR IBP Transducer Cable, 5ft - 989803194601 Expression MR FlexTEMP II Sensor - 989803194511 Expression MR Wireless SpO2 Patient Module (Gen 3)6-10 - 989803194331 Expression MR400 New MRI Monitor Accessories - 866428 Philips CareEvent Application Software Version B1 CareEvent EarlyVue VS30 (863380) EarlyVue VS30 Vital Signs Monitor Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A) Avalon Fetal & Maternal Patch Avalon Patient Module (M2738A) Avalon CL Fetal & Maternal Pod (866488) M1911A Fetal Monitoring Recording Paper Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA) Avalon Basestation (866074) Remote Event Marker (989803143411) 989803184851- Avalon Belt Clip M1910A Fetal Monitoring Recording Paper M2734B MECG Adapter Cable (M1363A) M1913J Fetal Monitoring Recording Paper M1913A Fetal Monitoring Recording Paper IntelliVue Patient Monitors, Philips IntelliBridge EC10 and EC5 ID Module Philips MP40, MP50, MP60, MP70, MP80, MP90, AND MX800 Philips IntelliVue TcG10 Measurement Module Flex Adapter Nissha Adult Electrode Quadtrode CV MRI ECG Electrode Pad - 989803179041 40494E, Limb Clamp Electrode QUADTRODE MRI ECG PAD,25/BOX - 989803179031 Neonatal Quadtrode MRI ECG Electrode Pad - 989803179051 ePatch ECG Electrode Patch ECG Electrode MCOT Patch Patch electrode ePatch electrode 2-CH Patch Universal Patch BTP-1000P (Patch) Patch Philips ECG Comfort Patch Lead Wire Adapter Gel, ECG/EEG, Skin Prep, Tube, 3-Pack BIS Module Expression MR FlexTEMP System, Jacket - 989803178181 IntelliVue NMT Hand Adapter Philips MP2 MP5 MP5TMP5SC MP20 MP30 MP40 MP50 MP60 MP70 MP80 MP90 MX600 MX700 MX800 Intellivue Pat. Monitors IntelliVue X2 Multi-Measurement Module NMT Module (865383) NMT Patient Cable (989803174581) 867040 - IntelliVue Capnography Extension 867041 - IntelliVue Microstream Extension CANNULA,DISP,INFANT (4200F) Philips IntelliVue Information Center iX, M3290B Software Holter 1810/ 2010 SW Patient Information Center iX (PIC iX) IntelliVue Patient Monitors MX430, MX700, MX800, MP5, MP5SC Cardiac Workstation 5000 CW 5000 (860439) CW 7000 (860441) Cardiac Workstation 7000 Wireless PIM Leadwire, 3mm needle AAMI (989803223951) Wireless PIM Leadwire, 4mm banana IEC (989803223961) IntelliVue Patient Monitor MX550 (866066) IntelliVue Patient Monitor MX400 (866060) IntelliVue Patient Monitor MX450 (866062) IntelliVue Patient Monitor MX500 (866064) 867036, IntelliVue Multi-Measurement Module MMX G7m Module IntelliVue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90, MX500, MX550, MX600, MX700, MX800 DigiTrak XT Holter Recorder w/Leadwires DL950 Holter System IntelliVue Multi-Measurement Module X3 (867030) IntelliVue Patient Monitor MX100 (867033) CS770 IntelliSpace Critical Care and Anesthesia H Expression IP5 Information Portal Expression MR200 MRI Patient Monitoring System NiBP Cuff, Single Lumen, Thigh - 989803182681 NiBP Cuff, Single Lumen, Infant #5, Disp - 989803183211 NiBP Cuff, Single Lumen, Infant - 989803182611 NiBP Cuff, Single Lumen, Adult-L - 989803182651 NiBP Cuff, Single Lumen, Neo #1, Disp - 989803183171 NiBP Cuff, Single Lumen, Pediatric - 989803182621 NiBP Cuff, Single Lumen, Lrg Adult-L - 989803182671 NiBP Cuff, Single Lumen, Sample Kit,Disp - 989803182591 NiBP Cuff, Single Lumen, Thigh, Disp - 989803182581 NiBP Cuff, Single Lumen, Lrg Adult - 989803182661 Expression IP5 Software Upgrade - 989803197491 NiBP Cuff, Single Lumen, Neo #4, Disp - 989803183201 NiBP Cuff, Single Lumen,Lrg Adult-L,Disp - 989803182571 NiBP Cuff, Single Lumen, Adult - 989803182641 NiBP Cuff, Single Lumen, Pediatric, Disp - 989803182521 NiBP Cuff, Single Lumen, Neo #3, Disp - 989803183191 NiBP Cuff, Single Lumen, Adult-L, Disp - 989803182551 NiBP Cuff, Single Lumen, Small Adult, Disp - 989803182531 NiBP Cuff, Single Lumen, Adult, Disp - 989803182541 NiBP Cuff, Single Lumen, Neo #2, Disp - 989803183181 Wireless SpO2 Patient Module - 989803183541 NiBP Cuff, Single Lumen, Infant, Disp - 989803182511 NiBP Cuff, Single Lumen, Lrg Adult, Disp - 989803182561 Advanced Apps ECG Cable - 989803176381 NiBP Cuff, Single Lumen, Small Adult - 989803182631 Expression MR Wireless ECG Patient Module - 989803183661 Expression MR200 New MRI Monitor Accessories - 866177 IntelliSpace ECG IntelliSpace ECG SW IntelliBridge System 12-Lead Patient Cables: 989803184921, 989803184931, 989803184941, 989803184951 PageWriter TC35 Cardiograph, TC35 (860437) 453564588501, Transpac IV Dual IBP Cable 867030, IntelliVue Multi-Measurement Module X3 867033, IntelliVue Patient Monitor MX100 867039, IntelliVue Hemodynamic Extension 867043, IntelliVue Dock 989803199741, Dual IBP Adapter Care Assist Patient Information Center iX, 866389 Quick Connect SpO2 Grip, Adult, 20/box - 989803166551 Quick Connect SpO2 Grip, Ped, 20/box - 989803166561 Quick Connect SpO2 Clip, Adult - 989803166531 Quick Connect SpO2 Probe, MRI - 989803161991 Quick Connect SpO2 Clip, Pediatric - 989803166541 CAB,4 LD,NEO.MRI ECG - 9222 SpO2 SENSOR GRIP ADULT/NEONATAL 2 PACK - 989803162501 GRIP SENSOR STARTER KIT - 989803162491 SpO2 SENSOR GRIP INFANT/PEDIATRIC 2 PACK - 989803162511 PNEUMOGRAPH, CHEST, NON-MAGNETIC, 3160 - 94023 Quick Connect SpO2 Grip, Infant, 20/box - 989803166571 KIT,SAMPLE,AGENTS,3160 - 94018 Anesthetic Oxygen (O2) Sensor - 989803162051 CUFFF,CHILD,MRI,COLDER CONN - 989803169441 CAB,4 LD,MRI ECG - 9224 Quick Connect SpO2 Starter Kit - 989803167111 Quick Connect SpO2 Grip, Neo, 20/box - 989803166581 Wireless SP02 Module (Gen 2) - 989803163111 Wireless ECG Module - 989803163121 ADVANCED FILTER ECG CABLE - 989803170121 Expression MR Cuff, Disp, NEO, MRI, Size #5 - 989803170421 Expression MR Cuff, Disp, NEO, MRI Size #3 - 989803170401 CAB,4 LD,CV MRI ECG - 9223 MRI Patient Monitoring System, Mode 867062 Philips IntelliSpace Perinatal Rev. K0 Small Architecture 867061 Philips IntelliSpace Perinatal Rev. K0 Large Architecture LoFlo Sample Line, Neo. Cannula, Box 20 - 989803183261 LoFlo Line, Adu Airway Adpt, Box 100 - 989803185381 LoFlo Sample Line, Adult Cannula, Box 20 - 989803183241 LoFlo Line, Ped Dvd Cannula, Box 100 - 989803185371 LoFlo Sample Line, Ped. Cannula, Box 20 - 989803183251 LoFlo Line, Adu Dvd Cannula, Box 20 - 989803183271 LoFlo Line, Adu Airway Adpt, Box 20 - 989803183291 LoFlo Line, Ped Dvd Cannula, Box 20 - 989803183281 LoFlo Line, Adu Dvd Cannula, Box 100 - 989803185361 989803194641, Expression MR IBP DPT Kit, I/N, Box 20 989803194631, Expression MR IBP DPT Kit, A/P, Box 20 TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device