ERGOSELECT 100 K/P, ERGOSELECT 200 K/P— 510(k) K053078

Name: FDA 510(k) clearance K053078
Creator: U.S. Food and Drug Administration
Published: 2006-04-27

Substantially Equivalent

Ergoline GmbH

FDA 510(k) clearance K053078 for ERGOSELECT 100 K/P, ERGOSELECT 200 K/P, Substantially Equivalent on 2006-04-27. Applicant: Ergoline GmbH. Device class: 2.

Clearance details

Applicant: Ergoline GmbH
Product code: Code ISD
Device class: Class 2
Regulation: 21 CFR 890.5360
Advisory panel: Physical Medicine
Date received: 2005-11-02
Decision date: 2006-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bitz, B-W, DE

Download summary PDF View on FDA.gov ↗

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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.