510(k) K863749

TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH by Teca, Inc. — Product Code GWQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 6, 1986
Date Received: September 24, 1986
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Full-Montage Standard Electroencephalograph
Device Class: Class II
Regulation Number: 882.1400
Review Panel: NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

Other clearances by Teca, Inc.

K962283 — EEG ELECTRODES (December 16, 1996)
K903731 — SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME (February 4, 1991)
K903004 — EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH (November 15, 1990)
K896666 — P460, DG32 ELECTROENCEPHALOGRAPH (February 16, 1990)
K894889 — TECA NEUROMAPPER 386 (December 22, 1989)
K894088 — TECA NEUROMAPPER 1620, BRAIN MAPPER (November 15, 1989)
K890881 — TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS (March 23, 1989)
K884870 — TECA/MEDELEC 'CONCEPT' P420 (February 23, 1989)
K880593 — TECA/MEDELEC MISTRAL (April 6, 1988)
K872931 — TECA/MEDELEC TTT THERMAL THRESHOLD TESTER (November 16, 1987)

Other clearances for product code GWQ

K260455 — New Wave System (March 13, 2026)
K233403 — Flexset System (April 30, 2024)
K231366 — Neuronaute Plus (November 9, 2023)
K221959 — Q21 (August 31, 2023)
K231457 — SPARK Scan (August 18, 2023)
K221963 — Cumulus Functional Neurophysiology Platform (April 27, 2023)
K230073 — Okti (February 9, 2023)
K223644 — Neuronaute with IceCap 2 & IceCap 2 Small (January 12, 2023)
K220056 — iSyncWave (August 10, 2022)
K212788 — Seer Home (June 16, 2022)