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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 K170185
Device Name tremoFlo C-100 Airwave Oscillometry System
Applicant
THORASYS Thoracic Medical Systems, Inc.
6560 Avenue de l'Esplanade Suite #103
Montreal,  CA H2v 4l5
Applicant Contact Sebastien Jutras
Correspondent
Smith Assoicates
1468 Harwell Avenue
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number868.1840
Classification Product Code
PNV  
Date Received01/23/2017
Decision Date 09/12/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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