Biofourmis Everion+ (G2)— 510(k) K233418

Name: FDA 510(k) clearance K233418
Creator: U.S. Food and Drug Administration
Published: 2024-05-09

Substantially Equivalent

Biofourmis Singapore Pte., Ltd.

FDA 510(k) clearance K233418 for Biofourmis Everion+ (G2), Substantially Equivalent on 2024-05-09. Applicant: Biofourmis Singapore Pte., Ltd.. Device class: 2.

Clearance details

Applicant: Biofourmis Singapore Pte., Ltd.
Product code: Code MSX
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2023-10-10
Decision date: 2024-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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