BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Philips Medizin Systeme Boeblingen GmbH

    Reg #: 9610816 · FEI: 3002807167 · Expires 2026
    View on FDA
    Products
    75
    Proprietary Names
    454
    Establishment Types
    6
    Classifications
    75

    Registration Details

    Registration Name
    Philips Medizin Systeme Boeblingen GmbH
    Registration Number
    9610816
    FEI Number
    3002807167
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    HEWLETT-PACKARD STRASSE 2
    City
    BOEBLINGEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K212227

    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
    Recorder, Paper Chart DSF
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    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
    Computer, Diagnostic, Programmable DQK
    Monitor, St Segment With Alarm MLD
    Display, Cathode-Ray Tube, Medical DXJ
    Generator, Electroencephalograph Test Signal GWR
    Electrocardiograph DPS
    Continuous Measurement Thermometer FLL
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    System, Signal Isolation DRJ
    Recorder, Magnetic Tape, Medical DSH
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Probe, Thermodilution KRB
    Stimulator, Nerve, Peripheral, Electric KOI
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Plethysmograph, Impedance DSB
    Transducer, Blood-Pressure, Extravascular DRS
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Adaptor, Lead Switching, Electrocardiograph DRW
    Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Monitor, St Segment MLC
    Tester, Electrode, Surface, Electrocardiographic KRC
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Spectrum, Electroencephalogram Signal GWS
    Monitor, Breathing Frequency BZQ
    Monitor, Carbon-Dioxide, Cutaneous LKD
    Calculator, Pulmonary Function Data BZC
    Clinical Electronic Thermometer SDV
    Medical Device Data System OUG
    System, Monitoring, Perinatal HGM
    Full-Montage Standard Electroencephalograph GWQ
    Oximeter, Tissue Saturation MUD
    System, Balloon, Intra-Aortic And Control DSP
    Antimicrobial Blood Pressure Cuff OED
    Electrode, Ion Specific, Calcium JFP
    Ph Rate Measurement, Carbon-Dioxide JFL
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Potassium CEM
    Burst Suppression Detection Software For Electroencephalograph ORT
    Index-Generating Electroencephalograph Software OLW
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Reduced- Montage Standard Electroencephalograph OMC
    Oximeter, Ear DPZ
    Urinometer, Electrical EXS
    Connector, Airway (Extension) BZA
    Electrode, Electrocardiograph DRX
    Uterine Electromyographic Monitor OSP
    Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia LPP
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Gas, Calibration (Specified Concentration) BXK
    Monitor, Uterine Contraction, External (For Use In Clinic) HFM
    Transducer, Ultrasonic, Obstetric HGL
    Plethysmograph, Photoelectric, Pneumatic Or Hydraulic JOM
    Transducer, Pressure, Intrauterine HFN
    Calculator/Data Processing Module, For Clinical Use JQP
    Stethoscope Head BZS
    Cable, Electrode IKD
    Stethoscope, Manual LDE

    Proprietary Names

    Thermal Printer Kit, USB (989803205011) MR Patient Care Portal 5000 (866162) 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 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 IntelliVue Patient Monitors MX430, MX700, MX800, MP5, MP5SC Veridia Patient Monitoring System M1921A Microstream® EtCO2 FilterLine H Set IntelliVue CL SpO2 Pod IntelliVue Patient Monitor MP5, MP5T, MP5SC SW Rev. J.20 CL NBP Pod SW Rev. B2 Mobile CL Adult Bayonet Air Hose 1m IntelliVue GuardianSoftware Revision Ex 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) 866009, Philips IntelliVue GuardianSoftware, SW Rev. C M1006B: IntelliVue Blood Pressure module M1029A: IntelliVue Temperature module X1(M3001A/AL) Philips IntelliVue MP2, MP5, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX400, MX450, MX500, MX550, MX600, MX700 Philips IntelliVue X2 Multi-Measurement Module with Software Revision L2 Disposable Adult / Pediatric SpO2 Sensor (M1131A) G7m Module IntelliVue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90, MX500, MX550, MX600, MX700, MX800 Predictive Temperature Module IntelliVue MMX Rev. R IntelliVue MX100, X3, MMX Rev. R IntelliVue XDS Software 867062 Philips IntelliSpace Perinatal Rev. K0 Small Architecture 867061 Philips IntelliSpace Perinatal Rev. K0 Large Architecture IntelliSpace ECG IntelliSpace ECG SW IntelliVue Patient Monitors MX450, MX500, MX550, MX600, MX700, MX800 and the Multi-Measurement Module X2 IntelliVue Patient Monitor XG50 - 866063 IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX400, MX430, MX450 IntelliVue Measurement Rack 6000 IntelliVue Patient Monitors Philips INF Nasal CO2 O2 Cannula Philips Sample Line Kit, M2776A Philips PED INF A ADPTR W HUMID, M2773A Philips ADU Oral Nasal CO2 Can, M2756A Philips ADU Nasal CO2 Cannula, M2744A Philips PED Nasal CO2 O2 Cannula, M2751A Philips ADU Nasal CO2 O2 Cannula, M2750A Philips ADU PED A ADPTR W Humid, M2772A Philips ADU Oral Nas CO2 O2 Can, M2760A Philips PED Oral Nasal CO2 Can, M2757A Philips PED INF Airway Adapter Philips PED Oral Nas CO2 O2 Can, M2761A Philips ADU PED Airway Adapter, M2768A CO2 Nasal Cannula - Infant Philips Sample Line W HUMID Kit, M2777A CO2 Nasal Cannula - Pediatric Essential Wireless Display, ROHS – 453564198611 Essential MRI Patient Monitor (Model 865353) IntelliVue 4-Slot Module Rack FMX-4 (866468) IntelliVue Patient Monitor MX850 (866470) IntelliVue Patient Monitor MX750 (866471) Tcp02/TcpCO2 Module GAS Cal 1 cylinders for TCPC02, 6/bx Reusable SpO2 Sensor 989803180831 Tethered Genius 2 Tympanic Thermometer 989803179381 Genius 2 Probe Covers 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 IntelliVue Patient Monitor 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 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 IntelliVue M1026B Anesthetic Gas Module Telemetry Monitor 5500 Release 4 Masimo Rainbow SET IntelliVue Module 866062 IntelliVue Patient Monitor MX450 866060 IntelliVue Patient Monitor MX400 BIS Module IntelliVue Guardian Software Rev. C.1 M3014A Capnography Extension Reusable NEO Airway Adapter, Philips Single-Patient Use Adult Airway Adapter Mainstream CO2 Sensor Reusable ADU-PED Airway Adapter, Philips Philips M3001A Multi Measurement Server IntelliVue EEG module (M1027B, 866078) IntelliVue GuardianSoftware SW Rev. A2 IntelliVue Patient Monitor MP2, SW Rev. J7 IntelliVue CL Respiration Pod, SW Rev. B IntelliVue Multi-Measurement Module X2, SW Rev. J7 IntelliVue Patient Monitor MP5, MP5T, MP5SC, SW Rev. J7 Mobile CL Respiration Pod Attachment IntelliVue Patient Monitor MX550 (866066) IntelliVue Patient Monitor MX400 (866060) IntelliVue Patient Monitor MX450 (866062) IntelliVue Patient Monitor MX500 (866064) 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) ISA CO2 Measurement Device IRMA CO2 Measurement Device Masimo O3 Measurement Device PHILIPS Masimo O3 Module PHILIPS Masimo CO2 Module URINOMETER, ELECTRICAL 989803205881 SPO2 Reus Neo Hnd-Ft Wrap Sensor M1193A 989803205871 SPO2 Reus Ped-Adult Glove Sensor M1192A IntelliVue Patient Monitor MX750 IntelliVue Patient Monitor MX850 IntelliVue 4-Slot module rack FMX-4 Viridia EEG SYSTEM, SIGNAL ISOLATION PageWriter TC20, TC30, TC50, TC70 w/PIM, Lead Sets, Adapters, Electrodes PageWriter TC20 989803175891, 12-Lead Patient Cable (IEC), Standard Length 989803175921, 12-Lead Patient Cable (AAMI), Long 989803175911, 12-Lead Patient Cable (IEC), Long 989803166031, Clear Tab/Snap Adapter 989803175901, 12-Lead Patient Cable (AAMI), Standard Length 989803129231, Alligator Clips, AMMI Anesthesia Gas Monitor Neonatal / Infant / Adult Disposable SpO2 Sensor (M1133A) Infant Disposable SpO2 Sensor (M1132A) IntelliVue MX400, MX450, MX500, MX550, Rev. R 989803197511 6-Lead Set, Patient Use Disposable, Bedside, AAMI 989803173151 5-Lead Set, Single Patient Use Disposable,Telemetry, AAMI 989803192151 5-Lead Set, Single Patient Use Disposable, Chest, IEC 989803173121 3-Lead Set, Single Patient Use Disposable, Bedside, AAMI 989803174211 5-Lead Set, Single Patient Use Disposable,Bedside, IEC 989803174201 3-Lead Set, Single Patient Use Disposable, Bedside, IEC 989803192141 5-Lead Set, Single Patient Use Disposable, Chest, AAMI 989803173131 5-Lead Set, Single Patient Use Disposable, Bedside, AAMI 989803197521 6-Lead Set, Single Patient Use Disposable, Bedside, IEC Patient Monitor 15mm Male/Female Adapter CapnoTrak Airway Adapter Set Reusable Neonatal CO2 Airway Adapter Neonatal Airway Adapter Pediatric/Adult Airway Adapter NOVA DISP AIRW ADPTRADLT 20/C Neonatal/Pediatric Airway Adapter Reusable Airway Adapter MaInstream CO2 Adult Pediatric/Adult Airway Adapter with Mouthpiece 15mm Male/Female Adapter Low Deadspace AA &TRAY ASSY, ADU, ZOLL MED 8000-0262 Adapter ADU Reuse Capnostat 704-0002-00 Neonatal and Pediatric CO2 Airway Adapter, Disposable Infant Airway Adapter, Disposable Zoll Neonatal Reusable Adapter, Qty 1 Pediatric and Adult CO2 Airway Adapter, Disposable Long and Short Extension Cable MP80, MP90, MX600, MX700 and MX800, SW Rev. J4 MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, IntelliVue Patient Monitor MP2, X2, MP5, MP5T, Avalon CL Fetal & Maternal (F&M) Pod (866488) Avalon CL Fetal & Maternal (F&M) Patch (989803196341) Philips Reusable ECG Lead Sets and Trunk Cables M1020B (862112) IntelliVue Pulse Oximetry Module MP40/50 IntelliVue Patient Monitor IntelliVue Patient Monitors, Philips IntelliBridge EC10 and EC5 ID Module Philips MP40, MP50, MP60, MP70, MP80, MP90, AND MX800 Philips IntelliVue TcG10 Measurement Module 13943B Solid Gel Tab Electrode, Resting ECG Expression MR FlexTEMP System, Jacket - 989803178181 Fetal Imaging System EarlyVue VS30 (863380) EarlyVue VS30 Vital Signs Monitor IntelliVue Patient Monitor 6500 IntelliVue Patient Monitor 6100 IntelliVue Patient Monitor 6300 IntelliVue Patient Monitor MX500, SW Rev. K.10 IntelliVue Patient Monitor MX550, SW Rev. K.10 IntelliVue Multi-Measurement Module X3 (867030) IntelliVue Patient Monitor MX100 (867033) GAS, CALIBRATION (SPECIFIED CONCENTRATION 867036, IntelliVue Multi-Measurement Module MMX 12-Lead Patient Cables: 989803184921, 989803184931, 989803184941, 989803184951 PageWriter TC35 Cardiograph, TC35 (860437) SpO2 Sensor 867040 - IntelliVue Capnography Extension 867041 - IntelliVue Microstream Extension CBL OR 5-Lead ECG Trunk Cable, AAMI/IEC - 989803170181 CBL OR 3-Lead ECG Trunk Cable, AAMI/IEC - 989803170171 Xper Information Management System Xper Flex Cardio Physiomonitoring System M3015B Microstream CO2 Measurement Server Extension 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 GuardianSoftware 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 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 SpO2 Reusable Clip Sensor Reusable SpO2 Sensor (M1196A and M1196T) M4602A Reusable Abdominal Belt- 60mm Wd,1.3M Lg M4603A Reusable Abdominal Belt- 60mm Wd, 15M LG M4601A Reusable Leg Belt- 32mm X 15M M2208A Disposable abdominal belts,100/cs M1562B Reusable abdominal/leg belt- 50mm X 1.3M Masimo SET IntelliVue Pulse Oximeter Module CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE 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 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 STETHOSCOPE HEAD 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 Cardiac Output Adapter Cable (M1642A) STETHOSCOPE, MANUAL 989803179541 Mobile CL Respiration Pod Attachment 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 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 Patient Physiological Monitor 989803203051 SedLine Measurement Device 989803203021 Masimo O3 Measurement Device 867185 PHILIPS Masimo CO2 Module 989803203041 IRMA CO2 Measurement Device 989803203031 ISA CO2 Measurement Device 867184 PHILIPS Masimo O3 Module 867186 PHILIPS Masimo SedLine Module M1943NL SpO2 Adapter Cable Reusable Adult/Pediatric Ear Clip SpO2 Sensor (1.5m) (M1194A) Sp02 8-pin D-sub Adapter cbl (8pin) Oxi (M1943NL) Reusable Pediatric/Small/Adult Finger SpO2 Sensor (M1192A) Reusable Neonatal Hand/Foot SpO2 Sensor (1.5m) (M1193A) M1134A Adhesive-free Neo/Inf/Adult SpO2 Sensor 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 IntelliVue MP40-MP90 Intellibridge EC5/EC10 module (865114,865115) IntelliVue MX750/MX850,Flexible Module Server FMX-4, Rev. R Care Assist Patient Information Center iX, 866389

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Remanufacture Medical Device Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device