Medical Device Manufacturer · US , Lakewood , CO

Gambro Renal Care Products - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1999

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gambro Renal Care Products Gastroenterology & Urology ✕

2 devices

1-2 of 2

Cleared May 23, 2003

GAMBRO POLYFLUX, MODEL 140H, 170H, 210H

Gastroenterology & Urology · 87d

Cleared Oct 06, 1999

PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)

Gastroenterology & Urology · 23d