HIGH SPEED EMG MODULE— 510(k) K031930

Substantially Equivalent

Medical Measurement Systems B.V.

FDA 510(k) clearance K031930 for HIGH SPEED EMG MODULE, Substantially Equivalent on 2004-03-03. Applicant: Medical Measurement Systems B.V..

Clearance details

Applicant: Medical Measurement Systems B.V.
Product code: Code GWF
Advisory panel: Neurology
Date received: 2003-06-23
Decision date: 2004-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Enschede Overijssel, NL

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.