SPECTRAL EEG MONITOR MODEL B500— 510(k) K913051

Name: FDA 510(k) clearance K913051
Creator: U.S. Food and Drug Administration
Published: 1991-08-20

Substantially Equivalent

Biometrak Corp.

FDA 510(k) clearance K913051 for SPECTRAL EEG MONITOR MODEL B500, Substantially Equivalent on 1991-08-20. Applicant: Biometrak Corp.. Device class: 2.

Clearance details

Applicant: Biometrak Corp.
Product code: Code OLT
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1991-07-09
Decision date: 1991-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLT

view all

K254213 — Pascall Sensor Unit (PSU1)2026-08-19
K253767 — UB ERP System2026-06-30
K251881 — HippoMind (v1.0)2025-12-03
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.