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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 K200870
Device Name Carnation Ambulatory Monitor
Applicant
Bardy Diagnostics, Inc
316 Occidental Avenue South, Suite B310
Seattle,  WA  98104
Applicant Contact Jocelyn Kersten
Correspondent
Bardy Diagnostics, Inc
316 Occidental Avenue South, Suite B310
Seattle,  WA  98104
Correspondent Contact Jocelyn Kersten
Regulation Number870.2800
Classification Product Code
DSH  
Date Received04/01/2020
Decision Date 05/01/2020
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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