Medical Device Manufacturer · US , Atlanta , GA

Scientific Intake - FDA 510(k) Cleared Devices

2 submissions · 1 cleared · Since 2016

2

Total

1

Cleared

1

Denied

FDA 510(k) Regulatory Record - Scientific Intake Gastroenterology & Urology ✕

2 devices

1-2 of 2

Cleared May 18, 2017

SmartByte Device

Gastroenterology & Urology · 28d

Not Cleared Sep 26, 2016

Sensor Monitored Alimentary Restriction Therapy (SMART) Device

DEN150033 · ONY

Gastroenterology & Urology · 423d