NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)— 510(k) K083371

Name: FDA 510(k) clearance K083371
Creator: U.S. Food and Drug Administration
Published: 2009-12-08

Substantially Equivalent

Natus Medical, Inc.

FDA 510(k) clearance K083371 for NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP), Substantially Equivalent on 2009-12-08. Applicant: Natus Medical, Inc.. Device class: 2.

Clearance details

Applicant: Natus Medical, Inc.
Product code: Code GWF
Device class: Class 2
Regulation: 21 CFR 882.1870
Advisory panel: Neurology
Date received: 2008-11-14
Decision date: 2009-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mudelein, IL, US

Download summary PDF View on FDA.gov ↗

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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.