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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Electrical Impedance Tomograph
510(k) Number K243765
Device Name LuMon(TM) System
Applicant
Sentec AG
Ringstrasse 39
Therwil,  CH 4106
Applicant Contact Caroline Moller
Correspondent
ProMedic Consulting, LLC
131 Bay Point Dr. NE
St Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.1505
Classification Product Code
QEB  
Date Received12/06/2024
Decision Date 08/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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