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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K180474
Device Name TNI softFlow 50
Applicant
TNI Medical AG
Hofmannstr. 8
Wuerzburg,  DE 97084
Applicant Contact Joseph P. McMenamin
Correspondent
THIRD PARTY REVIEW GROUP, LLC
25 Independence Blvd
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number868.5450
Classification Product Code
BTT  
Date Received02/22/2018
Decision Date 10/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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