Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003263092

FEI Number

3003263092

Entity Name

PULSION MEDICAL SYSTEMS SE

City/State/Country

Feldkirchen Bavaria, DE

Establishment Address

Hans-Riedl-Strasse 17, Feldkirchen Bavaria 85622, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Maquet Critical Care AB (Owner Number: 9036213)

Owner / Operator Contact Address

ROENTGENVAGEN 2, Solna, SE-NOTA SE-17154, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Inline Injectate temperature Probe PiCCO Module CeVOX Module PulsioFlex Monitor PICCO Temperature Probe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2022-12-22
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2018-01-25
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2017-11-15
MLC	Monitor, St Segment	Cardiovascular	Class 2	870.2340	2017-11-15
DRW	Adaptor, Lead Switching, Electrocardiograph	Cardiovascular	Class 2	870.2350	2017-11-15
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2017-11-15
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2017-11-15
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2017-11-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2017-11-15
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2017-11-15
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2017-11-15
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2017-11-15
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2017-11-15
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2017-11-15
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2017-11-15
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2017-11-15
LKD	Monitor, Carbon-Dioxide, Cutaneous	Anesthesiology	Class 2	868.2480	2017-11-15
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2017-11-15
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2017-11-15
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2017-11-15
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2017-11-15
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2017-11-15
KRC	Tester, Electrode, Surface, Electrocardiographic	Cardiovascular	Class 2	870.2370	2017-11-15
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2017-11-15
GWS	Analyzer, Spectrum, Electroencephalogram Signal	Neurology	Class 1	882.1420	2017-11-15
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2017-11-15
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2017-11-15
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2017-11-15
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2017-11-15
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2017-11-15
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2017-11-15
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2017-11-15
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2017-11-15
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2017-11-15
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2017-11-15
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2017-11-15
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2017-11-15
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2017-11-15
DRJ	System, Signal Isolation	Cardiovascular	Class 1	870.2600	2017-11-15
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2017-11-15
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2017-11-15

Official Correspondent

No official correspondent registered.

US Agent Details

Emily Valerio Email: emily.valerio@getinge.com Phone: (862) 2215193

Related Public Records

Same Entity

Maquet Critical Care AB

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8010042	MAQUET CRITICAL CARE AB	SOLNA Stockholm, SE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K051628	Draeger Medical Systems, Inc.	INFINITY MONITORS WITH SCIO MODIFICATIONS	2005-07-20
K972535	Odam	MAGLIFE C	1998-01-13
K170567	Remote Diagnostic Technologies , Ltd.	Tempus Pro Patient Monitor	2017-07-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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)]
Z-1729-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003263092. Last updated year: 2026. Please use registration number 3003263092 when referencing this establishment in official correspondence.