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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Impedance Measuring Device Utilizing Oscillation Techniques
510(k) Number K221024
Device Name tremoflo C2 Airwave Oscillometry System
Applicant
Thorasys Thoracic Medical Systems, Inc.
6560 Ave. De L'Esplanade Suite #103
Montreal,  CA H2V 4L5
Applicant Contact Paul Donnelly
Correspondent
Thorasys Thoracic Medical Systems, Inc.
6560 Ave. De L'Esplanade Suite #103
Montreal,  CA H2V 4L5
Correspondent Contact Christopher McLean
Regulation Number868.1840
Classification Product Code
PNV  
Date Received04/06/2022
Decision Date 06/20/2023
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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