510(k) K915154— GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS

Substantially Equivalent

C.G.H. Medical, Inc.

Clearance details

Applicant: C.G.H. Medical, Inc.
Product code: Code CAN
Advisory panel: Anesthesiology
Date received: 1991-11-14
Decision date: 1992-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Adverse events under product code CAN

product code CAN

Death: 4
Other: 1
Total: 5

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.