Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001570235

FEI Number

3001570235

Entity Name

GE Medical Systems Information Technologies, Inc.

City/State/Country

Waukesha, WI, US

Establishment Address

3114 N Grandview Blvd, Waukesha, WI 53188, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

GE HealthCare Technologies Inc. (Owner Number: 9912004)

Owner / Operator Contact Address

3000 N. Grandview Blvd, Waukesha, WI 53188, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222586

PMA Number

N/A

All Registered Proprietary Names

DURA-CUF CLASSIC-CUF SENSA-CUF SOFT-CUF NIBP Hoses NIBP connectors NIBP adaptors (Dinaclick, Bayonet, Neo-Snap) Centricity Perinatal MAC 7 Resting ECG Analysis System CARESCAPE V100 VITAL SIGNS MONITOR ProCare V3 CARESCAPE V100 B1X5-F2, Second Frame B125M Patient Monitor B105P Patient Monitor Monitor B105M Monitor B125M Monitor B155M B125P Patient Monitor Monitor B125P B105M Patient Monitor Monitor B105P B155M Patient Monitor CASE V7 Cardiac Testing System CardioSoft V7 Cardiac Testing System ComboLab AltiX AI.i MLCL Client Software AltiX AI.i CardioLab AltiX AI.i Mac-Lab AltiX AI.i Solar 8000i Transport Pro with Patient Data Mo Patient Data Module Defib Sync Cables B1X5-REC, Recorder CareIntellect Perinatal Mural Perinatal Surveillance CSCS CSCS v2 CARESCAPE Central Station CARESCAPE Central Station v2 CARESCAPE Central Station v3 CSCS v3 Portrait VSM Vital Signs Monitor Portrait VSM Portrait VSM CARESCAPE ONE CARESCAPE ECG CARESCAPE TEMP CARESCAPE PRES CARESCAPE SPO2 CARESCAPE DOCK FO MAC 3500 MAC 5500 HD MAC 5500 HD ECG ANALYSIS SYSTEM CAM HD CAM 14 Radial-Cuf Non-invasive Blood Pressure Cuff MLCL Client SW AltiX CardioLab AltiX ComboLab AltiX Mac-Lab AltiX Portrait Core Services CSSXB Portrait RR P-RR01 Portrait BCH01 Portrait MMP01 Portrait AAB01 Portrait SpO2 P-W01 Portrait SpO2 P-SP01 Portrait SBT01 Portrait SpO2 P-SE01 Portrait SpO2 P-SA01 Portrait RRP01 Portrait CVAXB Portrait HUBXB Portrait HSWXB Portrait CAU01 eMUSE Cardiology Information System MUSE Cardiology Information System MUSE Cardiology Information System V9 MUSE MUSE v9 MUSE NX MAC 5 A4 MAC 5 A4 Resting ECG Analysis System MAC 5 A5 MAC 5 Lite Resting ECG Analysis System MAC 5 Lite MAC 5 A5 Resting ECG Analysis System ECG Trunk Cables and Leadwires Trunk Cables (Cardiac Output Cables, Invasive Blood Pressure Cables, Temperature Cables) ECG Adapter Cable NOVII INTERFACE CABLE - GE FECG MECG Cable FECG Cable CLAB ECG Trunk Cable 12-lead AHA 10ft CLAB ECG Trunk Cable 12-lead IEC 10ft NOVII INTERFACE CABLE - GE MECG Novii Cables (NOVII INTERFACE CABLE - GE FECG; NOVII INTERFACE CABLE - GE MECG; NOVII INTERFACE CABLE - GE UA) 4 Leadwire Expansion Cable, grabber, IEC, 74 cm/29 in. NOVII INTERFACE CABLE - GE UA 4 Leadwire Expansion Cable, snap, IEC, 74 cm/29 in. 4 Leadwire Expansion Cable, grabber, IEC, 130 cm/51 in. Cable assembly ECG 3 lead neo IEC long, 3.6 m Cable assembly ECG 3 lead neo AHA short, 1.8 m Cable assembly ECG 3 lead neo AHA long, 3.6 m 4 Leadwire Expansion Cable, snap, IEC, 130 cm/51 in. Cable assembly ECG 3 lead neo IEC short, 1.8 m 4 Leadwire Expansion Cable, snap, AHA, 130 cm/51 in. 4 Leadwire Expansion Cable, grabber, AHA, 74 cm/29 in. 4 Leadwire Expansion Cable, snap, AHA, 74 cm/29 in. 4 Leadwire Expansion Cable, grabber, AHA, 130 cm/51 in. B125M Patient Monitor B1X5-F2, Second Frame B155M Patient Monitor B105P Patient Monitor Monitor B105M Monitor B125M B105M Patient Monitor VSP 4 Upgrade Software Monitor B155M Monitor B125P Monitor B105P B125P Patient Monitor CARESCAPE ONE CARESCAPE DOCK FO CARESCAPE PRES CARESCAPE TEMP CARESCAPE SPO2 CARESCAPE ECG EK12 V2 Mural Clinical Viewer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2012-11-07
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2012-11-21
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2012-11-21
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2026-01-30
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2026-01-30
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2026-01-30
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2026-01-30
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2010-11-09
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2010-11-09
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2010-11-09
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2010-11-09
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2022-04-04
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-04-04
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2022-04-04
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-04-04
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2022-04-04
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2022-04-04
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-04
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2022-04-04
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2022-04-04
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-04-04
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2022-04-04
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-04
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2022-04-04
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2022-04-04
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2022-04-04
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-04-04
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2022-04-04
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2022-04-04
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2022-04-04
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-04
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-04
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2022-04-04
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2022-04-04
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2022-04-04
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2022-04-04
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2022-04-04
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2022-04-04
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-12-20
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2025-01-16
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2010-07-13
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	1995-07-11
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2022-07-13
DXJ	Display, Cathode-Ray Tube, Medical	Cardiovascular	Class 2	870.2450	2016-09-19
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2016-09-19
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2016-09-19
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-04-26
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2024-04-26
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2024-04-26
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-04-26
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2024-04-26
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-04-26
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2020-03-30
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2020-03-30
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2020-03-30
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2020-03-30
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2020-03-30
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2020-03-30
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2020-03-30
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2020-03-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-03-30
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-03-30
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2020-03-30
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-03-30
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2020-03-30
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2020-03-30
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2011-05-11
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2011-05-11
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2011-05-11
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2013-04-16
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-02-18
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-03-23
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2024-03-23
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2024-03-23
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2024-03-23
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2024-03-23
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2016-01-15
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2022-10-31
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2022-10-31
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-10-31
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2018-06-06
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2026-05-14
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2026-05-14
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2026-05-14
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2026-05-14
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2026-05-14
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2026-05-14
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2026-05-14
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2026-05-14
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2026-05-14
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2026-05-14
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-05-14
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-05-14
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2026-05-14
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2026-05-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-05-14
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2026-05-14
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-05-14
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2026-05-14
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2026-05-14
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2026-05-14
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2026-05-14
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-05-14
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2026-05-14
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2026-05-14
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2026-05-14
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2026-05-14
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-05-14
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2022-04-27
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2022-04-27
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-04-27
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2022-04-27
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2022-04-27
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2022-04-27
QEM	Cerebral Oximeter	Cardiovascular	Class 2	870.2700	2022-04-27
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2022-04-27
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2022-04-27
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-04-27
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-04-27
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2022-04-27
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2022-04-27
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2022-04-27
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2022-04-27
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-04-27
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2022-12-22
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2023-01-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GE HealthCare Technologies Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3015060224	IMACTIS, SAS	SAINT MARTIN D'HERES, FR
2122726	GE MEDICAL SYSTEMS, LLC	Milwaukee, WI, US
9617766	GE BE PRIVATE LIMITED	WHITEFIELD, BANGALORE Karnataka, IN
9710090	GE ULTRASOUND KOREA, LTD.	Seongnam-Si Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K831001	Frontier Products	UNICUFF-BLOOD PRESSURE CUFF	1983-07-28
K253089	Shenzhen Best Electronics Co., Ltd.	NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)	2026-02-13
K972301	Rudolf Riester GmbH & Co. KG	BIG BEN SQUARE, BIG BEN ROUND	1997-09-17
K771196	Hewlett-Packard Co.	MARKER GENERATOR MODULES - 21597A	1977-08-03
K813458	Cranbury Medical Labs, Inc.	FETASCAN 1000, 1000A OBSTETRICAL DATA	1982-01-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-06	N/A	2	FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
Z-0036-06	N/A	2	FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)
Z-0011-2022	Welch Allyn Inc Mortara	2	ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX, MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX, ELI280-CAA-AAFBT, ELI280-DCD-ADFAD, ELI280-DDB-AACBX, ELI280-JXX-BDFAX, ELI280-CAA-ADCBX, ELI280-BCB-AACBD, ELI280-LDX-ADFBX, ELI280-LDX-ADCBX, ELI280-BDD-ADFAD, ELI280-BDB-AAFBD, ELI280-BDB-ACCAD, ELI280-BDB-ADFAD, ELI280-LDX-ADFBD, ELI280-DDB-AAFBD, ELI280-DCB-ACFAD, ELI280-AAA-BAFAF, MLBUR280-W1X, ELI280-DCB-AAABX, ELI280-AAA-ACAAX, ELI280-ADA-ABFBX, ELI280-BCB-AAFBD, ELI280-BCB-AAFBX, ELI280-CEA-ADFBX, ELI280-CDA-ADABX, ELI280-BDB-AAABX, ELI280-DDB-ACFBD, ELI280-DDB-BCFAX, ELI280-ADA-ADCAX, ELI280-BDB-AACBX, ELI280-BCB-ACAAX, BUR280-81X, ELI280-DCB-AAFBG, ELI280-BDB-AAFBT, ELI280-DCB-AAFAD, ELI280-CAA-ADFBX, ELI280-BDB-AAFBG, ELI280-BDB-AAFBX, ELI280-DCA-ACAAX, ELI280-CAB-ACFBX, ELI280-ADA-ACFAX, ELI280-CAA-AAFAT, ELI280-CAA-ACFBD, ELI280-CDA-ADCBX, ELI280-AAA-ADCBX, ELI280-CAA-AAFBD, ELI280-DCB-BAFBT, ELI280-BBA-AAAAX, ELI280-BBA-AAFAD, ELI280-DBA-AAFAD, ELI280-DCB-AAFBT, ELI280-DBA-ADFAX, ELI280-BBA-AAFBD, MLBUR280-C1X, ELI280-BBA-ADFAX, ELI280-DDD-ADFAD, ELI280-DBA-AAFAX, MLBUR280-W1D, ELI280-BCB-AACBX, ELI280-DCB-AACBD, ELI280-LDX-ADFBG, ELI280-DCB-AACBX, ELI280-DBA-ADFBD, ELI280-DDB-AAFBG, ELI280-DBA-AAABD, ELI280-DCB-AAFBX, ELI280-AAA-AAFBT, MLBUR280-C1D, ELI280-AAB-ADAAX, ELI280-DDB-AAFBT, ELI280-CAA-AACBX, ELI280-CEB-ACFBX, ELI280-CAA-ABFAX, ELI280-DDB-AAFBX, ELI280-DBA-AAAAX, ELI280-BCB-AAFBG, ELI280-BFA-ADCBX, ELI280-LDX-ADABX, MLBUR280-81D, ELI280-BBA-ADFAD, ELI280-CAA-ADHAX, ELI280-CEB-ACFBD, ELI280-AAB-ADCAD, ELI280-BDB-AACBD, ELI280-LDX-ADCBD, ELI280-AAB-ACCBX, ELI280-AAA-ABFBX, ELI280-DAB-ADCAD, ELI280-AFB-ABCBX, ELI280-DCB-AACAX, ELI280-DEB-ACFBD, ELI280-ADA-ACAAX, ELI280-AAB-ADFAD, ELI280-DCB-AAFBD, ELI280-CAA-AAAAX, ELI280-BDB-ACCAX, ELI280-CAA-AAFBX, ELI280-DDB-AAABX, ELI280-DCB-ACAAX, ELI280-CAA-ADFBD, ELI280-CBB-ACCBX, ELI280-DDB-AACBD, ELI280-DDB-ACCAX, ELI280-A, ELI280-DFA-ADCBX, ELI280-BCA-AAAAX, ELI280-DDB-AAAAX, ELI280-E, ELI280-C, ELI280-AAA-AAFBD, ELI280-DFC-ADFAD, BUR280-C1X, ELI280-D, ELI280-BAA-ACCBD, ELI280-AAA-AAAAX, BUR280-W1X, ELI280-B, ELI280-BCB-AAABX, ELI280-BCB-AACAX, BUR280-W1D, ELI280-F, ELI280-BCB-AAFAD, ELI280-BCB-BAFAX, BUR280-81D
Z-0041-2012	Edan Instruments, Inc. 7/F, Yuehai Office Bldg. 1128 Nanyou Road Nanshan, Shenzhen Guangdong China	2	ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph ECG cable is an accessory of the following machines: SE-1 series, SE-3 series and SE-601 series electrocardiograph (ECG). The EDAN ECG is a diagnostic and prescription device only intended to be used in hospitals or healthcare facilities by qualified doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help medical professionals to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. ECG cable is packed in plastic bag, as an accessory putting together with ECG machine in the package box.
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001570235. Last updated year: 2026. Please use registration number 3001570235 when referencing this establishment in official correspondence.