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

Clearance details

Applicant

Datex Division Instrumentarium Corp.

Product code

Code BSZ

Device class

Class 2

Regulation

21 CFR 868.5160

Advisory panel

Anesthesiology

Date received

1988-12-01

Decision date

1989-06-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Helsinki, Finland, FI

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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 →