DHL SUPPLY CHAIN (NETHERLANDS) B.V.

FDA Device Registration & Listing · Beringe Limburg, NL · Registration 3009077524

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009077524
FEI Number
3009077524
Entity Name
DHL SUPPLY CHAIN (NETHERLANDS) B.V.
City/State/Country
Beringe Limburg, NL
Establishment Address
Zwenkgras 9, Beringe Limburg 5986 PM, NL
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
DHL Supply Chain (Netherlands) B.V. (Owner Number: 10085309)
Owner / Operator Contact Address
Zwenkgras 15, Beringe, NL-NB 5986 PM, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K202216
PMA Number
N/A

All Registered Proprietary Names

IntelliVue Patient Monitor MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL dS Small Extremity 16CH 1.5T Coil PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304 HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL NVA-127-8-A NEUROVASCULAR ARRAY COIL CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM PUNCTURENEEDLE VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS DURADIAGNOST POLYGEL ULTRASOUND GEL VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51 ACHIEVA 1.5T & INERA 1.5T FAMILY Pinnacle Radiation Therapy Planning System Achieva 1.5T, 3T and Intera 1.5T MR Systems QSC-63-INT SHOULDER ARRAY COIL SET 1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484 MobileDiagnost wDR 2.2 SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM QUADRATURE LOWER EXTREMITY COIL PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A PercuNav Image Fusion and Interventional Navigation OBC-250-PAN BREAST ARRAY COIL SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 K-DEFIB/PACE, MODEL KDP-60A DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound Syste Guide, Needle, Surgical PRACTIX CONVENIO THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE PATIENT MONITORS CX50 DIAGNOSTIC ULTRASOUND SYSTEM PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE Expression MR400 MRI Patient Monitoring System ALLURA XPER FD20 ALLTECH ECHOSTAR 1.5 T MR SYSTEM CX50 DIAGNOSTIC ULTRASOUND SYSTEM ENDOSONICS AUTOMATIC PULL BACK DEVICE EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affin PAGEWRITER CARDIOGRAPH MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE Grid, Radiographic LBS-63-16 BREAST ARRAY COIL 3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL Xperius Ultrasound System PHILIPS EASY DIAGNOST HRH-63-8 HEAD ARRAY COIL PHILIPS M5066A AND M5068A SyncVision System CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16 1.5T AND 3T GENERAL PURPOSE FLEX COILS EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 HD11 DIAGNOSTIC ULTRASOUND SYSTEM VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM HD11 DIAGNOSTIC ULTRASOUND SYSTEM BIOPSY BREAST COIL, MODEL BBC HRK-63-8 KNEE ARRAY COIL Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound Syst MP5 INTELLIVUE PATIENT MONITOR DAUM BONE BIOPSY SET PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL DAUM MRI/CONVENTIONAL BIOPSY KIT HILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE SKINTACT ECG ELECTRODE ACHIEVA, INTERA AND PANORAMA 1T, RELEASE 2.5 DL900 SERIES HOLTER RECORDER ESSENTIAL MRI PATIENT MONITOR MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM SENSE MSK S 8CH 1.5T ProxiDiagnost N90 PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A INTELLIVUE MX40 PATIENT MONITOR Lumify Diagnostic Ultrasound System RALCO, MODEL R225 ACS EPIQ Diagnostic Ultrasound System SYNERGY HEAD/NECK COIL M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 HD15 DIAGNOSTIC ULTRASOUND SYSTEM Philips CombiDiagnost R90 INTELLIVUE PATIENT MONITOR HNC-63-INT NEUROVASCULAR ARRAY COIL DAUM DOUBLE-SHOOT BISOPSY GUN CX50 3 DIAGNOSTIC ULTRASOUND SYSTEM PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 PANORAMA 1T 1.5T and 3T 16 CH GE Shoulder Coils EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160 QSC-127-INT SHOULDER ARRAY COIL SET K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60 EPIQ DIAGNOSTIC ULTRASOUND SYSTEM NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System GYROSCAN INTERA (R7.5) ds Head 32ch 3T InnoSight Diagnostic Ultrasound System PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701 Lumify Ultrasound System MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR FUJI IP CASSETTE TYPE PC MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 IU22 ULTRASOUND SYSTEM AND TRANSDUCERS SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS IntelliVue Patient Monitor NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affi Guide, Surgical, Instrument SURESIGNS VS3, SURESIGNS VS4 SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O PHILIPS DUO DIAGNOST V-2200 INFANT INCUBATOR HRK-123 KNEE ARRAY COIL EDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201 LOFLO C5 CO2 SENSOR dS FootAnkle I6CH 1.5T Coil PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50 EPIQ Series Diagnostic Ultrasound Systems

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DRQ Amplifier And Signal Conditioner, Transducer Signal Cardiovascular Class 2 870.2060 2022-06-17
DSJ Alarm, Blood-Pressure Cardiovascular Class 2 870.1100 2022-06-17
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2022-06-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-06-17
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2022-06-17
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2022-06-17
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2022-06-17
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2022-06-17
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-06-17
MUJ System, Planning, Radiation Therapy Treatment Radiology Class 2 892.5050 2022-06-17
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2022-06-17
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2022-06-17
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-06-17
LIX Aid, Cardiopulmonary Resuscitation Cardiovascular Class 2 870.5210 2022-06-17
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2022-06-17
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2022-06-17
LDD Dc-Defibrillator, Low-Energy, (Including Paddles) Cardiovascular Class 2 870.5300 2022-06-17
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2022-06-17
LDD Dc-Defibrillator, Low-Energy, (Including Paddles) Cardiovascular Class 2 870.5300 2022-06-17
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2022-06-17
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2022-06-17
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2022-06-17
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2022-06-20
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2022-06-17
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2022-06-17
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2022-06-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-06-17
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2022-06-17
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2022-06-17
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2022-06-17
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2022-06-17
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
IXJ Grid, Radiographic Radiology Class 1 892.1910 2022-06-20
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
IXR Table, Radiographic, Tilting Radiology Class 2 892.1980 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2022-06-17
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2022-06-17
NOU Continuous, Ventilator, Home Use Anesthesiology Class 2 868.5895 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2022-06-17
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2022-06-17
NSA Over-The-Counter Automated External Defibrillator Cardiovascular Class 3 870.5310 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2022-06-17
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2022-06-17
KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia Anesthesiology Class 2 868.2500 2022-06-17
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2022-06-17
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-06-17
MWJ Electrocardiograph, Ambulatory (Without Analysis) Cardiovascular Class 2 870.2800 2022-06-17
DQA Oximeter Cardiovascular Class 2 870.2700 2022-06-17
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2022-06-17
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2022-06-17
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2022-06-17
HGM System, Monitoring, Perinatal Obstetrics/Gynecology Class 2 884.2740 2022-06-17
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
IZW Collimator, Automatic, Radiographic Radiology Class 2 892.1610 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
HGL Transducer, Ultrasonic, Obstetric Obstetrics/Gynecology Class 2 884.2960 2022-06-17
HGM System, Monitoring, Perinatal Obstetrics/Gynecology Class 2 884.2740 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2022-06-17
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2022-06-17
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2022-06-17
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
HGL Transducer, Ultrasonic, Obstetric Obstetrics/Gynecology Class 2 884.2960 2022-06-17
DRQ Amplifier And Signal Conditioner, Transducer Signal Cardiovascular Class 2 870.2060 2022-06-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-06-17
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2022-06-17
HGM System, Monitoring, Perinatal Obstetrics/Gynecology Class 2 884.2740 2022-06-17
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2022-06-17
DSJ Alarm, Blood-Pressure Cardiovascular Class 2 870.1100 2022-06-17
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2022-06-17
HFN Transducer, Pressure, Intrauterine Obstetrics/Gynecology Class 2 884.2700 2022-06-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-06-17
DSF Recorder, Paper Chart Cardiovascular Class 1 870.2810 2022-06-17
JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic Cardiovascular Class 2 870.2780 2022-06-17
DQA Oximeter Cardiovascular Class 2 870.2700 2022-06-17
HFM Monitor, Uterine Contraction, External (For Use In Clinic) Obstetrics/Gynecology Class 2 884.2720 2022-06-17
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2022-06-17
MSX System, Network And Communication, Physiological Monitors Cardiovascular Class 2 870.2300 2022-06-17
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2022-06-17
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2022-06-17
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2022-06-17
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2022-06-17
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-06-17
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-06-17
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
IZW Collimator, Automatic, Radiographic Radiology Class 2 892.1610 2022-06-17
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2022-06-17
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2022-06-17
DRJ System, Signal Isolation Cardiovascular Class 1 870.2600 2022-06-17
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2022-06-17
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-06-17
BZC Calculator, Pulmonary Function Data Anesthesiology Class 2 868.1880 2022-06-17
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2022-06-17
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2022-06-17
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-06-17
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2022-06-17
DSF Recorder, Paper Chart Cardiovascular Class 1 870.2810 2022-06-17
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2022-06-17
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-06-17
MSX System, Network And Communication, Physiological Monitors Cardiovascular Class 2 870.2300 2022-06-17
ORT Burst Suppression Detection Software For Electroencephalograph Neurology Class 2 882.1400 2022-06-17
KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia Anesthesiology Class 2 868.2500 2022-06-17
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2022-06-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-06-17
KRC Tester, Electrode, Surface, Electrocardiographic Cardiovascular Class 2 870.2370 2022-06-17
KRB Probe, Thermodilution Cardiovascular Class 2 870.1915 2022-06-17
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2022-06-17
KOI Stimulator, Nerve, Peripheral, Electric Anesthesiology Class 2 868.2775 2022-06-17
GWS Analyzer, Spectrum, Electroencephalogram Signal Neurology Class 1 882.1420 2022-06-17
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2022-06-17
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2022-06-17
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2022-06-17
DSP System, Balloon, Intra-Aortic And Control Cardiovascular Class 2 870.3535 2022-06-17
MLC Monitor, St Segment Cardiovascular Class 2 870.2340 2022-06-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-06-17
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2022-06-17
LKD Monitor, Carbon-Dioxide, Cutaneous Anesthesiology Class 2 868.2480 2022-06-17
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2022-06-17
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2022-06-17
DSH Recorder, Magnetic Tape, Medical Cardiovascular Class 2 870.2800 2022-06-17
DRQ Amplifier And Signal Conditioner, Transducer Signal Cardiovascular Class 2 870.2060 2022-06-17
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2022-06-17
DRW Adaptor, Lead Switching, Electrocardiograph Cardiovascular Class 2 870.2350 2022-06-17
DSJ Alarm, Blood-Pressure Cardiovascular Class 2 870.1100 2022-06-17
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-06-17
DQA Oximeter Cardiovascular Class 2 870.2700 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2022-06-20
DQA Oximeter Cardiovascular Class 2 870.2700 2022-06-17
DSJ Alarm, Blood-Pressure Cardiovascular Class 2 870.1100 2022-06-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-06-17
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2022-06-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-06-17
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2022-06-17
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2022-06-17
FMZ Incubator, Neonatal General Hospital Class 2 880.5400 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2022-06-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-06-17
HGM System, Monitoring, Perinatal Obstetrics/Gynecology Class 2 884.2740 2022-06-17
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2022-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-06-17

Official Correspondent

QHSE Beringe

US Agent Details

Jerry Doane Business: Pragmatic Compliance dba FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

DHL Supply Chain (Netherlands) B.V.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K190624 Philips Medizin Systeme Boeblingen GmbH EarlyVue VS30 2019-10-27
K891148 Del Mar Avionics MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM 1989-05-11
K914092 Nihon Kohden America, Inc. BSM-2100A CONFIGURED PATIENT MONITOR 1992-05-28
K153473 Braemar Manufacturing, LLC Braemar Telemetry Patch System 2016-07-22
K151681 Philips Medizin Systeme Boeblingen GmbH IntelliVue Patient Monitor 2015-07-17

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2025 Philips North America 2
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Z-0030-05 General Electric Medical Systems Information Technology 2
GE CIC Central Station Monitoring Product, Versions 3.x, 4.0.5, 4.0.6
Z-0034-2011 Philips Medical Systems North America Co. Phillips 2
The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.
Z-0035-2025 Philips North America 2
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001

Similar Registrations

Registration Number Establishment Name Location
2080783 NIHON KOHDEN AMERICA, INC. Irvine, CA, US
9610816 Philips Medizin Systeme Boeblingen GmbH BOEBLINGEN Baden-Wurttemberg, DE
1218950 Philips North America LLC ANDOVER, MA, US
3007603826 Shenzhen Mindray Bio-Medical Electronics Co.,LTD SHENZHEN Guangdong, CN
3012528160 Philips North America LLC Murrysville, PA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009077524. Last updated year: 2026. Please use registration number 3009077524 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.