TYPE PDU/CDU 9040 (SYSTEM ATHENA)— 510(k) K894700

Substantially Equivalent

S & W Medico Teknik

FDA 510(k) clearance K894700 for TYPE PDU/CDU 9040 (SYSTEM ATHENA), Substantially Equivalent on 1989-10-02. Applicant: S & W Medico Teknik.

Clearance details

Applicant: S & W Medico Teknik
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1989-07-24
Decision date: 1989-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

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Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.