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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 K231728
Device Name BiWaze Clear System
Applicant
ABMRC LLC
860 Blue Gentian Road Suite 200
Eagan,  MN  55121
Applicant Contact Leah Noaeill
Correspondent
ABMRC LLC
860 Blue Gentian Road Suite 200
Eagan,  MN  55121
Correspondent Contact Priyanka Paul
Regulation Number868.5905
Classification Product Code
NHJ  
Date Received06/13/2023
Decision Date 04/08/2024
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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