GAMBRO BICART 720G— 510(k) K940601

Substantially Equivalent

C.G.H. Medical, Inc.

FDA 510(k) clearance K940601 for GAMBRO BICART 720G, Substantially Equivalent on 1994-03-22. Applicant: C.G.H. Medical, Inc..

Clearance details

Applicant: C.G.H. Medical, Inc.
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 1994-02-10
Decision date: 1994-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.