ERGOSELECT/GE— 510(k) K112121

Substantially Equivalent

Ergoline GmbH

FDA 510(k) clearance K112121 for ERGOSELECT/GE, Substantially Equivalent on 2012-10-31. Applicant: Ergoline GmbH.

Clearance details

Applicant: Ergoline GmbH
Product code: Code ISD
Advisory panel: Physical Medicine
Date received: 2011-07-25
Decision date: 2012-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, Baden Wurttemberg, DE

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Adverse events under product code ISD

product code ISD

Other: 2
Total: 2

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.