SYSTEM ATHENA - PRODUCT ENHANCEMENTS— 510(k) K912049

Name: FDA 510(k) clearance K912049
Creator: U.S. Food and Drug Administration
Published: 1991-12-05

Substantially Equivalent

S & W Medico Teknik

FDA 510(k) clearance K912049 for SYSTEM ATHENA - PRODUCT ENHANCEMENTS, Substantially Equivalent on 1991-12-05. Applicant: S & W Medico Teknik. Device class: 2.

Clearance details

Applicant: S & W Medico Teknik
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 1991-04-09
Decision date: 1991-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

Download summary PDF View on FDA.gov ↗

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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.