LIFESCAN EVOKED POTENTIAL SYSTEM— 510(k) K861900

Name: FDA 510(k) clearance K861900
Creator: U.S. Food and Drug Administration
Published: 1986-08-25

Substantially Equivalent

Neurometrics

FDA 510(k) clearance K861900 for LIFESCAN EVOKED POTENTIAL SYSTEM, Substantially Equivalent on 1986-08-25. Applicant: Neurometrics. Device class: 2.

Clearance details

Applicant: Neurometrics
Product code: Code GWF
Device class: Class 2
Regulation: 21 CFR 882.1870
Advisory panel: Neurology
Date received: 1986-05-16
Decision date: 1986-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.