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

Name: FDA 510(k) clearance K915154
Creator: U.S. Food and Drug Administration
Published: 1992-05-27

Substantially Equivalent

C.G.H. Medical, Inc.

FDA 510(k) clearance K915154 for GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS, Substantially Equivalent on 1992-05-27. Applicant: C.G.H. Medical, Inc.. Device class: 1.

Clearance details

Applicant: C.G.H. Medical, Inc.
Product code: Code CAN
Device class: Class 1
Regulation: 21 CFR 868.2700
Advisory panel: Anesthesiology
Date received: 1991-11-14
Decision date: 1992-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

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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.