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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K220012
Device Name BresoDX1
Applicant
Bresotec, Inc.
55 York St. Unit 200
Toronto,  CA M5J 1R7
Applicant Contact Esther Sur
Correspondent
Bresotec, Inc.
55 York St. Unit 200
Toronto,  CA M5J 1R7
Correspondent Contact Mehrnaz Tabibi
Regulation Number868.2375
Classification Product Code
MNR  
Date Received01/04/2022
Decision Date 12/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT04897399
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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