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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 K233110
Device Name Carnation Ambulatory Monitor
Applicant
Bardy Diagnostics, Inc.
220 120th Ave. NE, Suite 100
Bellevue,  WA  98005
Applicant Contact Ben Hornsey
Correspondent
Bardy Diagnostics, Inc.
220 120th Ave. NE, Suite 100
Bellevue,  WA  98005
Correspondent Contact Ben Hornsey
Regulation Number870.2800
Classification Product Code
DSH  
Date Received09/27/2023
Decision Date 11/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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