510(k) K020046— MULTIGAS UNIT, MODEL AG-920RA

Substantially Equivalent

Nihon Kohden America, Inc.

Clearance details

Applicant: Nihon Kohden America, Inc.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2002-01-07
Decision date: 2002-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foothill, CA, US

Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

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.