FDA.reportPublic FDA data

1ST285-100 LuMon™ Belt Size 116

Primary DI
EIT11ST2851000
Brand
1ST285-100 LuMon™ Belt Size 116
Company
SenTec AG
Model
1ST285-100
Published
2025-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
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
EIT11ST2851000PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480797856
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
076401218816261ST272-100 LuMon™ Belt Size 191ST272-1002026-10-26
076401218816331ST273-100 LuMon™ Belt Size 221ST273-1002026-10-26
076401218816401ST274-100 LuMon™ Belt Size 261ST274-1002026-10-26
076401218816571ST275-100 LuMon™ Belt Size 301ST275-1002026-10-26
076401218816641ST276-100 LuMon™ Belt Size 351ST276-1002026-10-26
076401218816711ST277-100 LuMon™ Belt Size 401ST277-1002026-10-26
076401218816881ST278-100 LuMon™ Belt Size 471ST278-1002026-10-26
076401218816951ST282-100 LuMon™ Belt Size 801ST282-1002026-10-26
076401218817011ST283-100 LuMon™ Belt Size 921ST283-1002026-10-26
076401218817181ST284-100 LuMon™ Belt Size 1041ST284-1002026-10-26
076401218817251ST285-100 LuMon™ Belt Size 1161ST285-1002026-10-26
076401218817631ST120-100 LuMon™ Connector 2.01ST120-1002026-10-26
076401218817562ST200-100 LuMon™ Monitor2ST200-1002026-10-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
076401218816261ST272-100 LuMon™ Belt Size 19SenTec AGBZQ2026-10-26
076401218816261ST272-100 LuMon™ Belt Size 19SenTec AGQEB2026-10-26
076401218816331ST273-100 LuMon™ Belt Size 22SenTec AGBZQ2026-10-26
076401218816331ST273-100 LuMon™ Belt Size 22SenTec AGQEB2026-10-26
076401218816401ST274-100 LuMon™ Belt Size 26SenTec AGBZQ2026-10-26
076401218816401ST274-100 LuMon™ Belt Size 26SenTec AGQEB2026-10-26
076401218816571ST275-100 LuMon™ Belt Size 30SenTec AGBZQ2026-10-26
076401218816571ST275-100 LuMon™ Belt Size 30SenTec AGQEB2026-10-26
076401218816641ST276-100 LuMon™ Belt Size 35SenTec AGBZQ2026-10-26
076401218816641ST276-100 LuMon™ Belt Size 35SenTec AGQEB2026-10-26
076401218816711ST277-100 LuMon™ Belt Size 40SenTec AGBZQ2026-10-26
076401218816711ST277-100 LuMon™ Belt Size 40SenTec AGQEB2026-10-26
076401218816881ST278-100 LuMon™ Belt Size 47SenTec AGBZQ2026-10-26
076401218816881ST278-100 LuMon™ Belt Size 47SenTec AGQEB2026-10-26
076401218816951ST282-100 LuMon™ Belt Size 80SenTec AGQEB2026-10-26
076401218816951ST282-100 LuMon™ Belt Size 80SenTec AGBZQ2026-10-26
076401218817011ST283-100 LuMon™ Belt Size 92SenTec AGBZQ2026-10-26
076401218817011ST283-100 LuMon™ Belt Size 92SenTec AGQEB2026-10-26
076401218817181ST284-100 LuMon™ Belt Size 104SenTec AGBZQ2026-10-26
076401218817181ST284-100 LuMon™ Belt Size 104SenTec AGQEB2026-10-26
076401218817251ST285-100 LuMon™ Belt Size 116SenTec AGBZQ2026-10-26
076401218817251ST285-100 LuMon™ Belt Size 116SenTec AGQEB2026-10-26
076401218817631ST120-100 LuMon™ Connector 2.0SenTec AGBZQ2026-10-26
076401218817631ST120-100 LuMon™ Connector 2.0SenTec AGQEB2026-10-26
076401218817562ST200-100 LuMon™ MonitorSenTec AGQEB2026-10-23
076401218817562ST200-100 LuMon™ MonitorSenTec AGBZQ2026-10-23
07898966433023ENLIGHT BELT - P0 - LEFTTimpel S/AQEB2026-10-08
07898966433030ENLIGHT BELT - P0 - RIGHTTimpel S/AQEB2026-10-08
07898966433047ENLIGHT BELT - P1 - LEFTTimpel S/AQEB2026-10-08
07898966433054ENLIGHT BELT - P1 - RIGHTTimpel S/AQEB2026-10-08