510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K182030Substantially Equivalent

Faros Mobile

Bittium Biosignals Ltd., Kuopio, FI / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182030 is the FDA 510(k) clearance record for Faros Mobile, a class II device, cleared for Bittium Biosignals , Ltd. on under FDA product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm). FDA records list one 510(k) clearance for Bittium Biosignals , Ltd. As of , FDA records show no recalls naming K182030.

Clearance record

Decision date
Received
(101 days to decision)
Product code
MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Bittium Biosignals , Ltd. Pioneerinkatu 6, Kuopio, FI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MLO

Trailing 12 months
1 clearance under product code MLO in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MLO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260