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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
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