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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 K132206
Device Name MELYS ATRIAL FIBRILLATION SCREENING MONITOR
Applicant
Advanced Fluidics, LLC
1468 Harwell Ave.
Crofton,  MD  21114
Applicant Contact E J SMITH
Correspondent
Advanced Fluidics, LLC
1468 Harwell Ave.
Crofton,  MD  21114
Correspondent Contact E J SMITH
Regulation Number870.2920
Classification Product Code
DXH  
Date Received07/16/2013
Decision Date 03/19/2014
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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