Neo ADVISE software— 510(k) K230195

Name: FDA 510(k) clearance K230195
Creator: U.S. Food and Drug Administration
Published: 2024-03-08

Substantially Equivalent

Comerge AG

FDA 510(k) clearance K230195 for Neo ADVISE software, Substantially Equivalent on 2024-03-08. Applicant: Comerge AG. Device class: 2.

Clearance details

Applicant: Comerge AG
Product code: Code OLO
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2023-01-25
Decision date: 2024-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zurich, CH

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

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.