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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 K173793
Device Name XactTrace Single Use Respiratory Effort Belt System
Applicant
Embla Systems
1 Hines Road, Suite 202
Kanata,  CA K2K 3C7
Applicant Contact Sanjay Mehta
Correspondent
Embla Systems
1 Hines Road, Suite 202
Kanata,  CA k2k 3C7
Correspondent Contact Sanjay Mehta
Regulation Number868.2375
Classification Product Code
MNR  
Date Received12/14/2017
Decision Date 03/01/2019
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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