CARTOVAR BRAIN MAPPING ELECTRODIAGNOSTICS— 510(k) K853420

Name: FDA 510(k) clearance K853420
Creator: U.S. Food and Drug Administration
Published: 1986-02-07

Substantially Equivalent

Alvar

FDA 510(k) clearance K853420 for CARTOVAR BRAIN MAPPING ELECTRODIAGNOSTICS, Substantially Equivalent on 1986-02-07. Applicant: Alvar. Device class: 2.

Clearance details

Applicant: Alvar
Product code: Code OLT
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1985-08-14
Decision date: 1986-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLT

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K251366 — EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)2025-10-09
K240593 — VEEGix EEG System2024-08-23

Adverse events under product code OLT

product code OLT

Other: 1
Total: 1

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.