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510(k) K863749

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

K863749 is an FDA 510(k) premarket notification submitted by Teca, Inc. for the device "TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH". The FDA issued a decision of Substantially Equivalent on October 6, 1986. The device falls under product code GWQ (Full-Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Teca, Inc. has at least 10 other 510(k) clearances on record.

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

  • K261604 — Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) (June 13, 2026)
  • 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)

FDA data resources