Nicolet EDX— 510(k) K243982

Name: FDA 510(k) clearance K243982
Creator: U.S. Food and Drug Administration
Published: 2025-01-22

Substantially Equivalent

Natus Neurology Incorporated

FDA 510(k) clearance K243982 for Nicolet EDX, Substantially Equivalent on 2025-01-22. Applicant: Natus Neurology Incorporated. Device class: 2.

Clearance details

Applicant: Natus Neurology Incorporated
Product code: Code GWF
Device class: Class 2
Regulation: 21 CFR 882.1870
Advisory panel: Neurology
Date received: 2024-12-23
Decision date: 2025-01-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Middleton, WI, US

Download summary PDF View on FDA.gov ↗

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K234092 — SafeOp 3: Neural Informatix Systeem2024-04-19

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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.