FDA Registration Active 🇩🇪 Germany

PICCO Temperature Probe

Reg #: 3003263092 · FEI: 3003263092 · Expires 2025
Products
39
Proprietary Names
1
Establishment Types
1
Classifications
39

Registration Details

Registration Name
PULSION MEDICAL SYSTEMS SE
Registration Number
3003263092
FEI Number
3003263092
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Hans-Riedl-Strasse 17
City
Feldkirchen Bavaria
Country
DE

Regulatory Submissions

510(k) Number
K150310

Owner / Operator

Firm Name
Maquet Critical Care AB
Operator Number
9036213
Address
ROENTGENVAGEN 2
City
Solna
State
SE-NOTA
Postal Code
SE-17154
Country
SE

Products

Device Name Product Code
Monitor, St Segment MLC
System, Measurement, Blood-Pressure, Non-Invasive DXN
Adaptor, Lead Switching, Electrocardiograph DRW
Transducer, Blood-Pressure, Extravascular DRS
Detector And Alarm, Arrhythmia DSI
Recorder, Paper Chart DSF
Computer, Blood-Pressure DSK
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
Oximeter DQA
Burst Suppression Detection Software For Electroencephalograph ORT
System, Balloon, Intra-Aortic And Control DSP
Continuous Measurement Thermometer FLL
Monitor, St Segment With Alarm MLD
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
Monitor, Carbon-Dioxide, Cutaneous LKD
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK
Electrocardiograph DPS
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
Tester, Electrode, Surface, Electrocardiographic KRC
Cable, Transducer And Electrode, Patient, (Including Connector) DSA
Amplifier And Signal Conditioner, Transducer Signal DRQ
Analyzer, Spectrum, Electroencephalogram Signal GWS
Analyzer, Gas, Oxygen, Gaseous-Phase CCL
System, Network And Communication, Physiological Monitors MSX
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
Calculator, Pulmonary Function Data BZC
Computer, Diagnostic, Pre-Programmed, Single-Function DXG
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
Alarm, Blood-Pressure DSJ
System, Signal Isolation DRJ
Probe, Thermodilution KRB
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
Recorder, Magnetic Tape, Medical DSH
Stimulator, Nerve, Peripheral, Electric KOI
Monitor, Breathing Frequency BZQ

Proprietary Names

PICCO Temperature Probe

Establishment Types

Manufacture Medical Device