MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA— 510(k) K915633

Substantially Equivalent

S & W Medico Teknik

FDA 510(k) clearance K915633 for MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA, Substantially Equivalent on 1993-06-29. Applicant: S & W Medico Teknik.

Clearance details

Applicant: S & W Medico Teknik
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1991-10-29
Decision date: 1993-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

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Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.