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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K201208
Device Name Halo AF Detection System
Applicant
Livmor
16470 Bake Pkwy.
Suite 200
Irvine,  CA  92618
Applicant Contact Ken Persen
Correspondent
Livmor
16470 Bake Pkwy.
Suite 200
Irvine,  CA  92618
Correspondent Contact Ken Persen
Regulation Number870.2920
Classification Product Code
DXH  
Date Received05/05/2020
Decision Date 09/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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