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FDA 510(k)

Faros Mobile

K-Number: K182030 · 2018-11-08

ApplicantBittium Biosignals , Ltd.
Decision Date2018-11-08
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Faros Mobile is a medical device manufactured by Bittium Biosignals , Ltd.. It received FDA 510(k) clearance on 2018-11-08 under approval number K182030. The device is classified under product code MLO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Faros Mobile?

Faros Mobile is a medical device that received FDA 510(k) clearance on 2018-11-08. It is manufactured by Bittium Biosignals , Ltd.. The 510(k) number is K182030.

When was Faros Mobile approved by the FDA?

Faros Mobile received FDA 510(k) clearance on 2018-11-08, under approval number K182030.

What company makes Faros Mobile?

Faros Mobile is manufactured by Bittium Biosignals , Ltd..

What is the FDA product code for Faros Mobile?

The FDA product code for Faros Mobile is MLO.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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