Medical Device Manufacturer · SG , Singapore

Biosensors Intl. Pte. , Ltd. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2010

Recent clearances: THERMODILUTION CATHETER, THERMODILUTION CATHETER

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biosensors Intl. Pte. , Ltd. Cardiovascular ✕

2 devices

1-2 of 2

Cleared Jul 01, 2010

THERMODILUTION CATHETER

Cardiovascular · 17d

Cleared Jan 05, 2010

THERMODILUTION CATHETER

Cardiovascular · 414d