MAGPRO, MODEL R30— 510(k) K061645

Substantially Equivalent

Tonica Elektronik A/S

FDA 510(k) clearance K061645 for MAGPRO, MODEL R30, Substantially Equivalent on 2006-10-31. Applicant: Tonica Elektronik A/S.

Clearance details

Applicant: Tonica Elektronik A/S
Product code: Code GWF
Advisory panel: Neurology
Date received: 2006-06-12
Decision date: 2006-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farum, DK

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWF

product code GWF

Malfunction: 2,364
Other: 4
Total: 2,368

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.