Cleared Traditional

Everion+ System

K213863 · Biofourmis Singapore Pte., Ltd. · Cardiovascular

Feb 2023

Decision

440d

Days

Class 2

Risk

About This 510(k) Submission

K213863 is an FDA 510(k) clearance for the Everion+ System, a System, Network And Communication, Physiological Monitors (Class II — Special Controls, product code MSX), submitted by Biofourmis Singapore Pte., Ltd. (Singapore, SG). The FDA issued a Cleared decision on February 23, 2023, 440 days after receiving the submission on December 10, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K213863 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 10, 2021
Decision Date	February 23, 2023
Days to Decision	440 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF