510(k) K884991— CARDIOCAP CCK-104 KEYBOARD & CCP-104 GRAPHICS PRIN

Substantially Equivalent

Datex Division Instrumentarium Corp.

Clearance details

Applicant: Datex Division Instrumentarium Corp.
Product code: Code BSZ
Advisory panel: Anesthesiology
Date received: 1988-12-01
Decision date: 1989-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, Finland, FI

Adverse events under product code BSZ

product code BSZ

Death: 23
Injury: 298
Malfunction: 32,987
Total: 33,308

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.