ZAK-2000— 510(k) K972022

Substantially Equivalent

Cardio Systems, Inc.

FDA 510(k) clearance K972022 for ZAK-2000, Substantially Equivalent on 1998-01-22. Applicant: Cardio Systems, Inc..

Clearance details

Applicant: Cardio Systems, Inc.
Product code: 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

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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.