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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory, With Analysis Algorithm
510(k) Number K182030
Device Name Faros Mobile
Applicant
Bittium Biosignals , Ltd.
Pioneerinkatu 6
Kuopio,  FI FI-70800
Applicant Contact Taneli Vaaraniemi
Correspondent
Bittium Biosignals , Ltd.
Pioneerinkatu 6
Kuopio,  FI FI-70800
Correspondent Contact Taneli Vaaraniemi
Regulation Number870.2800
Classification Product Code
MLO  
Subsequent Product Codes
DSI   DXH  
Date Received07/30/2018
Decision Date 11/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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