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510(k) K182030

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

K182030 is an FDA 510(k) premarket notification submitted by Bittium Biosignals , Ltd. for the device "Faros Mobile". The FDA issued a decision of Substantially Equivalent on November 8, 2018. The device falls under product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm), a Class II device regulated under 21 CFR 870.2800.

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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  • K131897 — CV3000 HOLTER ANALYSIS SYSTEM (November 26, 2013)
  • K130660 — AUDICOR CPAM WITH SDB (SINGLE SENSOR) (October 11, 2013)
  • K120462 — AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED (September 20, 2012)
  • K111487 — NH-301 AMBULATORY ECG ANALYSIS SOFTWARE (November 10, 2011)
  • K110569 — AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) (October 24, 2011)

FDA data resources