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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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