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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 K181996
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  
Date Received07/26/2018
Decision Date 11/21/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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