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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K191471
Device Name Carnation Ambulatory Monitor
Applicant
Bardy Diagnostics, Inc.
316 Occidental Ave. S.
Suite B310
Seattle,  WA  98104
Applicant Contact Brit Baird
Correspondent
Bardy Diagnostics, Inc.
316 Occidental Ave. S.
Suite B310
Seattle,  WA  98104
Correspondent Contact Brit Baird
Regulation Number870.2800
Classification Product Code
DSH  
Date Received06/03/2019
Decision Date 08/30/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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