FDA.reportPublic FDA data

2ST200-100 LuMon™ Monitor

Primary DI
EIT12ST2001000
Brand
2ST200-100 LuMon™ Monitor
Company
SenTec AG
Model
2ST200-100
Device description
The LuMon™ Monitor is a noninvasive, non-radiological monitoring device that provides an assessment of regional impedance variation within a cross-section of a patient's thorax using an electrical impedance measuring device (LuMon™ Connector 2.0), an electrode belt (LuMon™ Belt) and a contact medium (LuMon™ Contact Gel).
Published
2025-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
BZQMonitor, Breathing Frequency
QEBVentilatory Electrical Impedance Tomograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZQMonitor, Breathing FrequencyAnesthesiology2
QEBVentilatory Electrical Impedance TomographAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243765000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243765000LuMon(TM) SystemSentec AG2025-08-07QEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EIT12ST2001000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Thoracic electrical impedance system, tomographicAn assembly of devices designed to perform continuous bioimpedance measurements throughout a cross-section of the thorax, to provide real-time feedback of lung function during controlled, assisted or spontaneous ventilation. It typically consists of a mobile trolley, an electrically-powered unit with a monitor and controls, connecting cables, and an electrode chest belt (typically with 16-32 electrodes). The technique [electrical impedance tomography (EIT)] uses single-frequency, low-amplitude alternating current applied by a pair of electrodes whereby the generated electrical potentials at the body surface are continuously measured by other electrodes.

Regulatory Flags#

DUNS number
480797856
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640121880803Multi-Site Attachment Ring for fragile/sensitive skinMARe-SF2019-01-29
07640121880810Ear Clip easyECe-MI2020-03-31
07640121880964Patient Application Kit for mature intact skinPAK-MI2021-09-26
07640121880971Patient Application Kit for sensitive/fragile skinPAK-SF2021-09-26
07640121881039Non-Adhesive Wrap1035202023-07-21
07640121880988103149 Calibration Gas1031492024-07-05
07640121880995103164 tCOM+1031642024-07-05
07640121881008103420 Sensor Adapter Cable (Regular)1034202024-07-05
07640121881015103421 Sensor Adapter Cable (Long)1034212024-07-05
07640121881022103422 Sensor Adapter Cable (Extra Long)1034222024-07-05
07640121880957Patient Application Kit with Ear Clip for mature/intact skinPAK-EC2021-09-26
07640121880889SDM Water Protection CoverSDM_WPC2021-08-25
07640121880902Isolation Transformer 100-120VRFT100VA-V12021-05-05
07640121880933Membrane Changer (single-use) / single unitMC2021-02-28
17640121880862Contact GelGEL-SD2019-03-05
07640121880018Sentec Digital MonitorSDM2016-08-31
07640121880032Digital Sensor Adapter Cable, 150 cmAC-1502016-08-31
07640121880049Ear ClipEC-MI2016-08-31
07640121880056Service gasGAS-08122016-08-31
07640121880070Contact GelGEL-042016-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.BZQ2025-12-10
07640121881053103583 LuMon™ Contact Gel KitSenTec AGBZQ2025-09-08
10889483610565Resmed Sleep Apnealink CannulaSALTER LABSBZQ2025-07-11
20860006382302SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack)Analog Devices, Inc.BZQ2025-03-13
17290020154009BB-613P Chest-Monitor 40-Unit MultipackBIOBEAT TECHNOLOGIES LTDBZQ2025-03-05
G2331000000SansaTMHuxley Medical, Inc.BZQ2024-10-21
G2331000010SansaTMHuxley Medical, Inc.BZQ2024-10-21
G2331000020SansaTMHuxley Medical, Inc.BZQ2024-10-21
10843997006184Radius VSMMASIMO CORPORATIONBZQ2024-08-19
08720256776529Corsano CardioWatch 287-2 SystemCorsano Health B.V.BZQ2024-06-19
07898959841163ENLIGHT ADDERE - XXSTimpel S/AQEB2024-05-13
07898959841217ENLIGHT ADDERE - XLTimpel S/AQEB2024-05-13
07898959841385ENLIGHT ADDERE - P0Timpel S/AQEB2024-05-13
07898959841392ENLIGHT ADDERE - P1Timpel S/AQEB2024-05-13
07898959841408ENLIGHT ADDERE - P2Timpel S/AQEB2024-05-13
07898959841477ENLIGHT ADDERE - 4STimpel S/AQEB2024-05-13
07898959841484ENLIGHT ADDERE - 5STimpel S/AQEB2024-05-13
00195278656681Portrait CVAXBGE Medical Systems Information Technologies, Inc.BZQ2024-04-30
00195278659446Portrait CSSXBGE Medical Systems Information Technologies, Inc.BZQ2024-04-30
00195278697165PORTRAIT HSWXBGE Healthcare Finland OyBZQ2024-04-30
00195278713193Portrait HUBXBGE Healthcare Finland OyBZQ2024-04-30
00195278699916PORTRAIT AAB01GE Healthcare Finland OyBZQ2023-10-26
00195278120014PORTRAIT SBT01GE Healthcare Finland OyBZQ2023-09-12
00195278223401PORTRAIT RRP01GE Healthcare Finland OyBZQ2023-09-12
00195278093998PORTRAIT HUB01GE Healthcare Finland OyBZQ2023-09-01
00195278094001PORTRAIT BCH01GE Healthcare Finland OyBZQ2023-09-01
00195278110435PORTRAIT MMP01GE Healthcare Finland OyBZQ2023-09-01