MAGLIFE C/MAGLIFE C PLUS— 510(k) K023195

Substantially Equivalent

Schiller Medical S.A.

FDA 510(k) clearance K023195 for MAGLIFE C/MAGLIFE C PLUS, Substantially Equivalent on 2003-06-03. Applicant: Schiller Medical S.A..

Clearance details

Applicant: Schiller Medical S.A.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2002-09-25
Decision date: 2003-06-03
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Wissembourg Cedex, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.