Medical Device Manufacturer · US , Lakewood , CO

C.G.H. Medical, Inc. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1991

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - C.G.H. Medical, Inc. Gastroenterology & Urology ✕

9 devices

1-9 of 9

Cleared May 12, 1995

COBE CENTRYSYSTEM CS500 DIALYZER

Gastroenterology & Urology · 401d

Cleared Jan 25, 1995

GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER

Gastroenterology & Urology · 539d

Cleared Sep 30, 1994

CENTRYSYSTEM 3 WITH CHARTS/BP OPTION

Gastroenterology & Urology · 697d

Cleared Aug 05, 1994

FILTRAL HEMODIALYZERS

Gastroenterology & Urology · 898d

Cleared Jul 07, 1994

LUNDIA ALPHA 700 HEMODIALYZER

Gastroenterology & Urology · 456d

Cleared Jun 27, 1994

HEMOSPAL KIT B22 / MULTIFLOW 60 KIT

Gastroenterology & Urology · 664d

Cleared Mar 22, 1994

GAMBRO BICART 720G

Gastroenterology & Urology · 40d

Cleared Mar 06, 1992

GAMBRO LUNDIA ALPHA HEMODIALYZERS

Gastroenterology & Urology · 88d

Cleared Aug 07, 1991

HEMOSPAL KIT B22

Gastroenterology & Urology · 119d