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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 K222466
Device Name AirTom
Applicant
Bilab
5f Ubiquoss Bldg., 68 Pangyo-Ro 255beon-Gil, Bundang-Gu
Seongnam-Si,  KR 13486
Applicant Contact Sang Keun Lee
Correspondent
Bilab
5f Ubiquoss Bldg., 68 Pangyo-Ro 255beon-Gil, Bundang-Gu
Seongnam-Si,  KR 13486
Correspondent Contact Eung Je Woo, Ph.D.
Regulation Number868.1505
Classification Product Code
QEB  
Date Received08/16/2022
Decision Date 06/30/2023
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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