Cleared Abbreviated

Faros Mobile

K182030 · Bittium Biosignals , Ltd. · Cardiovascular

Nov 2018

Decision

101d

Days

Class 2

Risk

About This 510(k) Submission

K182030 is an FDA 510(k) clearance for the Faros Mobile, a Electrocardiograph, Ambulatory, With Analysis Algorithm (Class II — Special Controls, product code MLO), submitted by Bittium Biosignals , Ltd. (Kuopio, FI). The FDA issued a Cleared decision on November 8, 2018, 101 days after receiving the submission on July 30, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number	K182030 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 30, 2018
Decision Date	November 08, 2018
Days to Decision	101 days
Submission Type	Abbreviated
Review Panel	Cardiovascular (CV)
Summary	Summary PDF