BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Philips North America LLC

    Reg #: 1218950 · FEI: 1218950 · Expires 2026
    View on FDA
    Products
    39
    Proprietary Names
    257
    Establishment Types
    4
    Classifications
    39

    Registration Details

    Registration Name
    Philips North America LLC
    Registration Number
    1218950
    FEI Number
    1218950
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3000 Minuteman Rd
    City
    ANDOVER
    State
    MA
    ZIP
    01810
    Country
    US

    Regulatory Submissions

    510(k) Number
    K871412

    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
    Electrode, Electrocardiograph DRX
    Electrocardiograph, Ambulatory (Without Analysis) MWJ
    Computer, Blood-Pressure DSK
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Alarm, Blood-Pressure DSJ
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    System, Network And Communication, Physiological Monitors MSX
    Blood Pressure Cuff DXQ
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Detector And Alarm, Arrhythmia DSI
    Oximeter DQA
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Continuous Measurement Thermometer FLL
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Monitor, St Segment With Alarm MLD
    Adaptor, Lead Switching, Electrocardiograph DRW
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass DRY
    Computer, Diagnostic, Programmable DQK
    Tape And Bandage, Adhesive KGX
    Bilirubin (Total And Unbound) In The Neonate Test System MQM
    Transducer, Blood-Pressure, Extravascular DRS
    Monitor, Uterine Contraction, External (For Use In Clinic) HFM
    Recorder, Paper Chart DSF
    System, Monitoring, Perinatal HGM
    Transducer, Ultrasonic, Obstetric HGL
    Plethysmograph, Photoelectric, Pneumatic Or Hydraulic JOM
    Transducer, Pressure, Intrauterine HFN
    Cable, Electrode IKD
    Electrocardiograph DPS
    Display, Cathode-Ray Tube, Medical DXJ
    Electrocardiograph, Ambulatory, With Analysis Algorithm MLO
    Antimicrobial Blood Pressure Cuff OED
    Uterine Electromyographic Monitor OSP
    Recorder, Magnetic Tape, Medical DSH
    Medical Device Data System OUG

    Proprietary Names

    13955C Neonatal/Pediatric Snap Electrode, Square 13953E Radiolucent Preattached Leadwire Electrode, Square 13953D Metallic Preattached Leadwire Electrode, Square 13952D Metallic Preattached Leadwire Electrode, Medium 13951C Neonatal/Pediatric Solid Gel Electrode 13952A Preattached Leadwire Electrode medium 13953B Preattached leadwire electrode square 13952B Preattached Leadwire electrode medium 13953A Preattached Leadwire electrode square DigiTrak XT Holter Recorder w/Leadwires DL950 Holter System 989803163201 Mobile CL Disposable Adult Cuff 989803163191 Mobile CL Reusable Adult Cuff 989803163181 Mobile CL Disposable Small Adult Cuff 989803163221 Mobile CL Disposable Large Adult Cuff IntelliVue Multi-Measurement Module X2, SW Rev. H1 IntelliVue Patient Monitor MP5, MP5T, MP2, SW Rev. H1 IntelliVue Telemetry System Transceiver TRx4841A, SW Rev. D Diverse Specialized Accessories and IntelliVue CL 865220 charging station 989803163211 Mobile CL Reusable Large Adult Cuff IntelliVue CL SpO2 Pod, CL NBP Pod SW Rev. A 989803163251 Mobile CL NBP Cradle Kit 989803168881 Mobile CL Transmitter Cradles 989803203561 Esophageal/Rectal Temperature Probe 12 Fr, Reusable, Autoclavable 21075A Esophageal/Rectal 12 Fr Temperature Probe 21078A Skin Surface Temperature Probe 989803203571 Esophageal/Rectal Temperature Probe 10 Fr, Reusable, Autoclavable 989803203581 Skin Temperature Probe, Reusable, Autoclavable 21076A Esophageal/Rectal 10 Fr Temperature Probe 989803192931, SureSigns VS Temporal Temperature HH 989803180831, Genius 2 tympanic temperature probe 863286, SureSigns VS4 Government Bundle 13943B Solid Gel Tab Electrode, Resting ECG 989803148821 Radiolucent Foam Electrode M1872S Neonatal Soft Single-Patient Cuff Size#4 989803167551 Neonatal Soft Single-Patient NIBP Cuffs M1868S Neonatal Soft Single-Patient Cuff Size#2 M1866S Neonatal Soft Single-Patient Cuff Size#1 M1872B Neonatal Single-Patient Cuff Size #4 M1873S Infant Soft Single-Patient Cuff Size #5 M1866B Neonatal Single-Patient Cuff Size #1 989803167541 Neonatal Single-Patient NIBP Cuffs M1868B Neonatal Single-Patient Cuff Size #2 M1870S Neonatal Soft Single-Patient Cuff Size#3 M1873B Infant Single-Patient Cuff Size #5 M1870B Neonatal Single-Patient Cuff Size #3 INTELLIVUE MX40 PATIENT MONITOR 989803171841 ECG 5 lead Snaps, AAMI + SpO2, Tele 989803171951 ECG 5 lead Grabber, IEC + SpO2, Tele 989803199081 MX40 Adapter SpO2-only 989803171831 ECG 5 lead Grabber, AAMI, Tele 989803199101 MX40 Adapter 3L+SpO2 989803171811 ECG 3 lead Grabber, AAMI + SpO2, Tele 989803171971 CBL ECG 6 Lead Grabber, IEC+SpO2, Tele 989803199071 ECG 6 lead Grabber, IEC + SpO2, Tele 989803171871 CBL ECG 6lead Grabber, AAMI + SpO2, Tele 989803171931 ECG 5 lead Grabber, IEC, Tele 989803171961 ECG 6 lead Grabber, IEC, Tele 989803171861 ECG 6 lead Grabber, AAMI, Tele 989803171821 ECG 5 lead Snaps, AAMI, Tele 989803199091 MX40 Adapter 5L+SpO2 989803171911 ECG 3 lead Grabber, IEC + SpO2, Tele 989803171851 ECG 5 lead Grabber, AAMI + SpO2, Tele MX40 Release B7 989803156201 Adult Disposable Metallic 3 Leadwire Electrode Set, AAMI 989803156241 Adult Disposable Metallic 5 Leadwire Electrode Set, AAMI 989803156231 Adult Disposable Radiolucent 3 Leadwire Electrode Set, IEC 989803156221 Adult Disposable Radiolucent 3 Leadwire Electrode Set, AAMI 989803156261 Adult Disposable Radiolucent 5 Leadwire Electrode Set, AAMI 989803156271 Adult Disp Radiolucent 5 Leadwire Electrode Set, IEC Telemetry Monitoring System Snap Style Foam Electrode 989803101301 HI-Tack Foam Wet Gel ECG Electrode 40420A HI-Tack Foam Wet Gel ECG Electrode Blood pressure monitor IntelliSpace ECG IntelliSpace ECG SW B800-11 BilEclipse, 50 Pack M4612A Solid Gel Foam Electrode 989803192551 Clear Tape Wet Gel ECG Electrode M4613A Solid Gel Foam Electrode Philips ST/AR ST 989803205391 Philips Nasal Alar SpO2 Sensor 989803205381 Philips Nasal Alar SpO2 Sensor 989803205401 Philips Nasal Alar SpO2 Sensor B800-500 BiliCal; 50 Pack 1037632 Bilichek (Advanced) 989803183081 Mini NeoLead, AAMI metal lead 989803183121 NeoLead, AAMI radio lead 989803183101 989803183101 989803183141 Micro NeoLead, AAMI radio lead CareEvent 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 M2202A Radiolucent Foam Electrode M1532A ECG Cable M1672A ECG Cable EEG Leadset - 989803180531 M1976A ECG Cable M1663A ECG Trunk Cable EEG Leadset - 989803180561 M1680A ECG Cable M1979A ECG Cable M1602A ECG Cable M1626A ECG Cable M1669A ECG Trunk Cable M1665A ECG Trunk Cable M1681A ECG Cable M1673A ECG Cable M1968A ECG Cable M1644A ECG Cable M1675A ECG Cable M1624A ECG Cable M1949A ECG Trunk Cable M1671A ECG Cable M1674A ECG Cable M1978A ECG Cable M1645A ECG Cable M1973A ECG Cable EEG Leadset - 989803180521 M1667A ECG Trunk Cable M1974A ECG Cable M1971A ECG Cable M1678A ECG Cable M2268A EEG Trunk Cable M1934A EEG Leadset CBL 5 Lead, Snap, Shld, AAMI, Chest, Rgd - 989803176171 M1668A ECG Trunk Cable EEG Leadset - 989803180541 CBL 5 Lead, Snap, Shld, AAMI, Limb, Rgd - 989803176161 M1533A ECG Cable CBL 5 Lead, Snap, Shld, IEC, Limb, Rgd - 989803176181 989803157501, DigiTrak XT Patient Cable, Long 989803157481, DigiTrak XT Patient Cable, short 989803157491, DigiTrak XT Patient Cable, Medium BTP-1000L-2-Lead Wire Adapter Flex Adapter BTP-1000A-Hybrid Patch Lead Wire Adapter OMNI-TRAK 3000 SERIES SureSigns VS Temporal Temperature HH - 989803192931 Philips IntelliVue Information Center iX, M3290B Software 989803183311 Multi Care Cuff, Infant 989803183361Multi Care Cuff, Large Adult 989803183351 Multi Care Cuff, Adult XL 989803183321 Multi Care Cuff, Pediatric 989803183371 Multi Care Cuff, Thigh 989803183331 Multi Care Cuff, Small Adult 989803183341 Multi Care Cuff, Adult M1572A Comfort Care Cuff, Pediatric M1573A Comfort Care Cuff, Small Adult M1575A Comfort Care Cuff, Large Adult M1574A Comfort Care Cuff, Adult M1571A Comfort Care Cuff, Infant M1576A Comfort Care Cuff, Thigh M1574XL Comfort Care Cuff, Adult XL 40477A Chemical/Thermal Paper M3708A Chemical/Thermal Paper M4816A Thermal Paper M2485A Chemical/Thermal Paper 989803190381 Efficia 50mm Chemical Thermal Paper, No Gridlines M4817A Thermal Paper 989803185271 Thermal Roll Paper, 110 mm Wide 989803138171 Defibrillator Chemical/Thermal Paper M3707A Chemical/Thermal Paper M2481A Chemical/Thermal Paper M1710A Chemical/Thermal Paper M2483A Chemical/Thermal Paper 40457C Chemical/Thermal Paper 989803138181 Defibrillator Chemical/Thermal Paper 989803151771, 15/16/18-Lead Upgrade Kit (AAMI), Long 989803151641, 12-Lead Complete Lead Set (IEC), Standard Length 989803164281, USB Patient Data Cable, Class B 989803151781, 15/16/18-Lead Upgrade Kit (IEC), Long 989803151661, 12-Lead Complete Lead Set (IEC), Long 989803151691, 12-Lead Chest Lead Set (AAMI/IEC), Long 989803151711, 12-Lead Limb Lead Set (AAMI/IEC), Standard Length 989803151671, 12-Lead Chest Lead Set (AAMI/IEC), Standard Length 989803151751, 15/16/18-Lead Upgrade Kit (AAMI), Standard Length 989803151651, 12-Lead Complete Lead Set (AAMI), Long 989803151761, 15/16/18-Lead Upgrade Kit (IEC), Standard Length 989803151631, 12-Lead Complete Lead Set (AAMI), Standard Length 989803151731, 12-Lead Limb Lead Set (AAMI/IEC), Long CBL OR 5-Lead ECG Trunk Cable, AAMI/IEC - 989803170181 CBL OR 3-Lead ECG Trunk Cable, AAMI/IEC - 989803170171 Intellivue MX40 Patient Monitor 989803172031 SPU ECG Lead Set, 5 Lead, AAMI, Grabber 989803172131 SPU ECG Lead Set, 5 Lead, AAMI, Grabber 989803172221 ECG 5L Grabber, AAMI, SpO2, Tele 989803172051 ECG 5 lead Graber, AAMI + SpO2, SPU, Tele 989803172151 ECG 5 lead Grabber, IEC + SpO2,SPU,Tele MX40 989803202421 ECG 5L Grabber, IEC, Masimo SpO2 , Tele 989803204291 MX40 Adapter 6-Lead + Masimo SpO2 989803202411 ECG 5L Grabber, AAMI, Masimo SpO2 , Tele 989803202391 MX40 Adapter Masimo SpO2-only 989803202381 MX40 Adapter 5-Lead + Masimo SpO2 CS770 IntelliSpace Critical Care and Anesthesia H Holter 1810/ 2010 SW 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 Gel, ECG/EEG, Skin Prep, Tube, 3-Pack M4555B Easy Care Cuff Adult M4576B Gentle Care Cuff, Adult XL M4578B Gentle Care Cuff, Large Adult XL 989803182291 Single Care Cuff, Small Adult 989803182301 Single Care Cuff, Adult 989803182311 Single Care Cuff, Adult XL 989803182321 Single Care Cuff, Large Adult 989803182281 Single Care Cuff, Pediatric M4558B Easy Care Cuff Lrg Adult XL M4557B Easy Care Cuff Lrg Adult M4552B Easy Care Cuff, 1 Hose, Infant (1) M4553B Easy Care Cuff, 1 Hose, Pediatric (1) M4574B Gentle Care Cuff Small Adult M4573B Gentle Care Cuff Pediatric M4556B Easy Care Cuff Adult XL M4577B Gentle Care Cuff Large Adult M4554B Easy Care Cuff Sm Adult M4572B Gentle Care Cuff Infant M4559B Easy Care Cuff Thigh M4575B Gentle Care Cuff Adult 989803196341 Avalon CL Fetal & Maternal Patch 40493E Foam Wet Gel ECG Electrode 40493D Foam Wet Gel ECG Electrode Patient Information Center iX (PIC iX) ST80i Stress Test System w/ Printer, Lead Sets, Electrodes 989803180131, ST80i 12-Lead Complete Lead Set (IEC), Standard Length, Grabber 989803180141, ST80i 12-Lead Complete Lead Set (AAMI), Standard Length, Snaps 989803180121, ST80i 12-Lead Complete Lead Set (AAMI), Standard Length, Grabber 989803180151, ST80i 12-Lead Complete Lead Set (IEC), Standard Length, Snaps ST80i Stress Test System

    Establishment Types

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