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510(k) K182030

Faros Mobile by Bittium Biosignals , Ltd. — Product Code MLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2018
Date Received
July 30, 2018
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

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