ELECTROENCEPHALOMYOGRAPH— 510(k) K810359

Name: FDA 510(k) clearance K810359
Creator: U.S. Food and Drug Administration
Published: 1981-03-13

Substantially Equivalent

Thoracel Research Labs.

FDA 510(k) clearance K810359 for ELECTROENCEPHALOMYOGRAPH, Substantially Equivalent on 1981-03-13. Applicant: Thoracel Research Labs.. Device class: 2.

Clearance details

Applicant: Thoracel Research Labs.
Product code: Code OLT
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1981-02-10
Decision date: 1981-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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

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.