9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT— 510(k) K930134

Substantially Equivalent

S & W Medico Teknik

FDA 510(k) clearance K930134 for 9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT, Substantially Equivalent on 1993-04-09. Applicant: S & W Medico Teknik.

Clearance details

Applicant: S & W Medico Teknik
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1993-01-12
Decision date: 1993-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.