510(k) K965016— ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)

Substantially Equivalent

Gibeck, Inc.

Clearance details

Applicant: Gibeck, Inc.
Product code: Code CAH
Advisory panel: Anesthesiology
Date received: 1996-12-16
Decision date: 1997-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Adverse events under product code CAH

product code CAH

Death: 7
Total: 7

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.