K972022

Substantially Equivalent

ZAK-2000

Applicant: Cardio Systems, Inc.
Product code: FNM
Advisory panel: General Hospital
Date received: 1997-06-02
Decision date: 1998-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carrollton, TX, US

Adverse events under product code FNM

product code FNM

Death: 22
Injury: 349
Other: 4
Total: 375

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.