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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 K250464
Device Name Enlight 2100 (TPL-E2103-0)
Applicant
Timpel S.A.
Rua Simão Álvares, 356 Cj 41/42
São Paulo,  BR 05.417-020
Applicant Contact Rafael Holzhacker
Correspondent
ProMedic Consulting, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.1505
Classification Product Code
QEB  
Subsequent Product Code
BZK  
Date Received02/18/2025
Decision Date 09/10/2025
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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