510(k) K894088

TECA NEUROMAPPER 1620, BRAIN MAPPER by Teca, Inc. — Product Code OLT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 15, 1989
Date Received: June 8, 1989
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Non-Normalizing Quantitative Electroencephalograph Software
Device Class: Class II
Regulation Number: 882.1400
Review Panel: NE
Submission Type

Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.

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)
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)
K862906 — TECA/MEDELEC AS-10 SENSOR (February 4, 1987)

Other clearances for product code OLT

K251881 — HippoMind (v1.0) (December 3, 2025)
K251366 — EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS- (October 9, 2025)
K240593 — VEEGix EEG System (August 23, 2024)
K220254 — Neuron-Spectrum-AM with Neuron-Spectrum.NET Software (November 30, 2022)
K213299 — Wireless EEG System (May 11, 2022)
K191322 — E-EEGX, N-EEGX (January 22, 2020)
K192572 — CNS Envision (December 17, 2019)
K190760 — Cadwell Bolt Software (November 23, 2019)
K143487 — Lifelines iEEG (August 21, 2015)
K142834 — DiscoverEEG System, Model DE-401 (June 23, 2015)