Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005783425

FEI Number

3005783425

Entity Name

DRAEGER MEDICAL SYSTEMS, INC.

City/State/Country

ANDOVER, MA, US

Establishment Address

6 TECH DRIVE, ANDOVER, MA 01810, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Draeger Medical Systems, Inc. (Owner Number: 9070398)

Owner / Operator Contact Address

6 Tech Drive, Andover, MA 01810, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K070566

PMA Number

N/A

All Registered Proprietary Names

FI02 Sensor Cable Gateway Infinity Gateway Suite Infinity Gateway Suite Infinity Trident NMT Pod Infinity Trident Pod System Infinity Acute Care System (IACS) Monitoring System Y-Adapter PS120 Desktop Power Supply Infinity Acute Care System (IACS) Monitoring Solution - C500 Cockpit Infinity Acute Care System (IACS) Monitoring Solution - M540 P2500 Power Supply Infinity Acute Care System (IACS) Monitoring Solution - C700 Cockpit Infinity Acute Care System (IACS) Monitoring Solution - M500 Docking Station Infinity M-Cable Masimo Rainbow Set etCO2 Airway Adaptor - Sidestream etCO2 Airway Adaptor-Neonatal etCO2 Airway Adaptor - Adult Infinity Symphony Suite Symphony Infinity CentralStation Wide Infinity CentralStation Infinity Gamma XL Infinity Gamma Infinity Vista Infinity Masimo SpO2 SmartPod SpO2 MasimoSet Pod Set Kit SpO2 Masimo Pod Infinity etCO2 SmartPod etCO2 Pod Kit Infinity etCO2 Module CNAP Accessories Infinity CNAP SmartPod Infinity Docking Station MIB II MIB II Protocol Converter Infinity Kappa XLT etCO2 Respiratory Mech SmartPod Infinity tpO2 / tpCO2 Smart Pod INFINITY OMEGA S SOLUTION INFINITY EXPLORER INFINITY OMEGA MONITOR INFINITY EXPLORER MONITOR INFINITY OMEGA SOLUTION Infinity CentralStation Infinity 300 Infinity M-Cable Rainbow SET Infinity Acute Care System IACS Masimo Rainbow SET M-Cable Infinity M-Cable Analog/Sync Infinity M-Pod Quad Hemo Infinity M-Cable Masimo SET Infinity M-Cable Dual Hemo Infinity M-Cable Nellcor OxiMax Infinity M540 NeoMed Pod Infinity Hemo 4 Pod Infinity Vista XL Infinity BisX Pod MultiMed Pod MultiMed Plus OR Infinity HemoMed MultiMed Plus Infinity Gamma XXL Infinity Hemo 2 Pod

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2007-12-13
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2007-12-13
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2022-12-29
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2006-11-07
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-04-05
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2022-04-05
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2022-04-05
FLS	Monitor, Apnea, Facility Use	Anesthesiology	Class 2	868.2377	2022-04-05
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-05
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2022-04-05
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2022-04-05
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-05
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2022-04-05
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2022-04-05
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2022-04-05
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2022-04-05
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2022-04-05
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2022-04-05
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2022-04-05
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2022-04-05
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2022-04-05
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2022-04-05
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2022-04-05
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2022-04-05
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2022-04-05
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2022-04-05
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2022-04-05
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-05
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2022-04-05
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-05
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-04-05
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-04-05
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2022-04-05
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2022-04-05
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2022-04-05
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2022-04-05
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2022-04-05
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2015-08-07
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2006-11-07
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2025-01-15
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2007-12-13
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2007-12-13
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2006-11-07
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2011-02-11
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2011-02-11
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2011-03-01
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2007-12-13
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2007-12-13
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-04-19
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2011-02-11
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2015-10-26
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2013-04-15
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2013-04-16
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2013-04-16
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2013-04-16
FLS	Monitor, Apnea, Facility Use	Anesthesiology	Class 2	868.2377	2013-04-16
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-04-16
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2013-04-16
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2013-04-16
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2013-04-16
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2013-04-16
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2013-04-16
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2013-04-16
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2007-12-13

Official Correspondent

Melissa Gray

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Draeger Medical Systems, 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
2510954	DRAEGER MEDICAL SYSTEMS, INC.	Telford, PA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K051628	Draeger Medical Systems, Inc.	INFINITY MONITORS WITH SCIO MODIFICATIONS	2005-07-20
K072469	Digiflo, Inc.	DIGIFLO CONCENTRATOR ANALYZER	2008-01-03
K993974	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR	2000-02-22
K182075	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)	2018-12-10
K972535	Odam	MAGLIFE C	1998-01-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0020-2025	Philips North America Llc	2	IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Z-1027-2026	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
Z-1321-2023	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus Pro Patient Monitoring units: Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R
Z-1666-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005783425. Last updated year: 2026. Please use registration number 3005783425 when referencing this establishment in official correspondence.