TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH— 510(k) K863749

Name: FDA 510(k) clearance K863749
Creator: U.S. Food and Drug Administration
Published: 1986-10-06

Substantially Equivalent

Teca, Inc.

FDA 510(k) clearance K863749 for TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH, Substantially Equivalent on 1986-10-06. Applicant: Teca, Inc.. Device class: 2.

Clearance details

Applicant: Teca, Inc.
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1986-09-24
Decision date: 1986-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasantiville, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWQ

view all

K261604 — Enobio Dx (3 models)2026-06-13
K260455 — New Wave System2026-03-13
K233403 — Flexset System2024-04-30
K231366 — Neuronaute Plus2023-11-09
K221959 — Q212023-08-31

More clearances from Teca, Inc.

view all

K962283 — EEG ELECTRODES1996-12-16
K903731 — SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME1991-02-04
K903004 — EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH1990-11-15
K896666 — P460, DG32 ELECTROENCEPHALOGRAPH1990-02-16
K894889 — TECA NEUROMAPPER 3861989-12-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.