Cleared Traditional

Biofourmis Everion+ (G2)

K233418 · Biofourmis Singapore Pte., Ltd. · Cardiovascular

May 2024

Decision

212d

Days

Class 2

Risk

About This 510(k) Submission

K233418 is an FDA 510(k) clearance for the Biofourmis Everion+ (G2), 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 May 9, 2024, 212 days after receiving the submission on October 10, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K233418 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 10, 2023
Decision Date	May 09, 2024
Days to Decision	212 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF