FDA 510(k)

Faros Mobile

K-Number: K182030 · 2018-11-08

Decision Date2018-11-08

Product CodeMLO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Faros Mobile is the device name listed in this FDA 510(k) record. The listed applicant is Bittium Biosignals , Ltd.. It received FDA 510(k) clearance on 2018-11-08 under 510(k) 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. The listed applicant is Bittium Biosignals , Ltd.. The 510(k) number is K182030.

When did Faros Mobile receive FDA 510(k) clearance?

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

Who is the listed applicant for Faros Mobile?

The FDA 510(k) record lists Bittium Biosignals , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Faros Mobile?

The FDA product code for Faros Mobile is MLO.

Related Devices (Code: MLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241890Philips Holter Analysis SystemPhilips Medizin Systeme Böblingen GmbH K240794Frontier X PlusFourth Frontier Technologies Pvt, Ltd.K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.K193177CER-SCardiocalm

Official Source

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