TECA NEUROPTO WITH OS-5 STIMULATOR— 510(k) K861069

Substantially Equivalent

Teca, Inc.

FDA 510(k) clearance K861069 for TECA NEUROPTO WITH OS-5 STIMULATOR, Substantially Equivalent on 1987-01-27. Applicant: Teca, Inc.. Device class: 2.

Clearance details

Applicant: Teca, Inc.
Product code: Code GWE
Device class: Class 2
Regulation: 21 CFR 882.1890
Advisory panel: Neurology
Date received: 1986-03-20
Decision date: 1987-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasantiville, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWE

K221471 — E3 and Profile2022-11-22
K212936 — Vision Monitor- MonCvONE2022-11-21
K211974 — LED PHOTIC System2021-09-23
K211643 — Vision Monitor - MonpackONE2021-07-26
K200705 — Nurochek System2020-04-23

More clearances from Teca, Inc.

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.