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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 K222897
Device Name Enlight 2100
Applicant
Timpel S.A.
R. Simao Alvares, 356 Cj. 41/42 - Pinheiros
Sao Paulo,  BR 05417-020
Applicant Contact Rafael Holtzhacker
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 Received09/23/2022
Decision Date 03/07/2023
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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