CS-MAG II— 510(k) K121825

Substantially Equivalent

Biomagnetik-Park GmbH

FDA 510(k) clearance K121825 for CS-MAG II, Substantially Equivalent on 2013-03-11. Applicant: Biomagnetik-Park GmbH.

Clearance details

Applicant: Biomagnetik-Park GmbH
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2012-06-21
Decision date: 2013-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamburg, DE

Download summary PDF View on FDA.gov ↗

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.