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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 K163665
Device Name MATRx plus
Applicant
Zephyr Sleep Technologies
610A 70 Ave SE
Calgary,  CA T2H-2J6
Applicant Contact Sabina Bruehlmann
Correspondent
Zephyr Sleep Technologies
610A 70 Ave SE
Calgary,  CA T2H-2J6
Correspondent Contact Sabina Bruehlmann
Regulation Number868.2375
Classification Product Code
MNR  
Date Received12/27/2016
Decision Date 05/05/2017
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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