FDA.reportPublic FDA data

510(k) K243765

Device
LuMon(TM) System
Applicant
Sentec AG
510(k) number
K243765
Product code
QEB
Decision
Substantially Equivalent (SESE)
Decision date
2025-08-07
Date received
2024-12-06
Regulation
868.1505
Classification name
Ventilatory Electrical Impedance Tomograph
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Caroline Moller
Address
Ringstrasse 39 Therwil CH 4106 4106

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QEB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250464Enlight 2100 (TPL-E2103-0)Timpel S.A.2025-09-10
K222466AirTomBilab2023-06-30
K222897Enlight 2100Timpel S.A.2023-03-07
K211135Enlight 2100Timpel S.A.2022-01-06
DEN170072Enlight 1810Timpel, Inc.2018-12-20