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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, positive pressure breathing, intermittent
510(k) Number K191912
Device Name BiWaze Cough
Applicant
ABMRC LLC
239, Fair Child Street, Daniel Island
Charleston,  SC  29492
Applicant Contact Chad M Boerst
Correspondent
ABMRC LLC
239, Fair Child Street, Daniel Island
Charleston,  SC  29492
Correspondent Contact Sneha S P
Regulation Number868.5905
Classification Product Code
NHJ  
Date Received07/17/2019
Decision Date 03/27/2020
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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