ASSISTO ARM SYSTEMS— 510(k) K052745

Substantially Equivalent

Geomed Medizin-Technik GmbH & Co.

FDA 510(k) clearance K052745 for ASSISTO ARM SYSTEMS, Substantially Equivalent on 2005-11-23. Applicant: Geomed Medizin-Technik GmbH & Co..

Clearance details

Applicant: Geomed Medizin-Technik GmbH & Co.
Product code: Code GWG
Advisory panel: Neurology
Date received: 2005-09-30
Decision date: 2005-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amsterdam, Nh, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

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.