Medical Device Manufacturer · US , Arden Hills , MN

Transoma Medical - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2007

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Transoma Medical Cardiovascular ✕

2 devices

1-2 of 2

Cleared May 18, 2009

SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL...

Cardiovascular · 24d

Cleared Dec 03, 2007

SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08

Cardiovascular · 25d