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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K233580
Device Name A Breathing System (ABS)
Applicant
Deepwell Dtx, Inc.
5608 17 Ave. NW Suite 570
Seattle,  WA  98107
Applicant Contact Jeff Harris
Correspondent
Deepwell Dtx, Inc.
14330 178th Lane NE
Woodinville,  WA  98072
Correspondent Contact Caitlyn Dzhafarov
Regulation Number882.5050
Classification Product Code
HCC  
Date Received11/07/2023
Decision Date 08/01/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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