Medical Device Manufacturer · SG , Singapore

Biofourmis Singapore Pte., Ltd. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2019

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biofourmis Singapore Pte., Ltd. Cardiovascular ✕

4 devices

1-4 of 4

Cleared May 09, 2024

Biofourmis Everion+ (G2)

Cardiovascular · 212d

Cleared Feb 23, 2023

Everion+ System

Cardiovascular · 440d

Cleared Aug 15, 2019

Biovitals Analytics Engine

Cardiovascular · 262d

Cleared Mar 07, 2019

RhythmAnalytics

Cardiovascular · 191d