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

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..

Clearance details

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

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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.