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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 K200695
Device Name MATRx plus
Applicant
Zephyr Sleep Technologies
102, 701 64 Ave SE
Calgary,  CA T2H-2C3
Applicant Contact Sabina Bruehlmann
Correspondent
Zephyr Sleep Technologies
102, 701 64 Ave SE
Calgary,  CA T2H-2C3
Correspondent Contact Sabina Bruehlmann
Regulation Number868.2375
Classification Product Code
MNR  
Subsequent Product Code
QCJ  
Date Received03/17/2020
Decision Date 08/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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