Faros Mobile— 510(k) K182030

Substantially Equivalent

Bittium Biosignals , Ltd.

FDA 510(k) clearance K182030 for Faros Mobile, Substantially Equivalent on 2018-11-08. Applicant: Bittium Biosignals , Ltd..

Clearance details

Applicant: Bittium Biosignals , Ltd.
Product code: Code MLO
Advisory panel: Cardiovascular
Date received: 2018-07-30
Decision date: 2018-11-08
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Kuopio, FI

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.