Home / 510(k) Clearances / K842886

510(k) K842886

TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL by Teca, Inc. — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1984
Date Received
July 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nystagmograph
Device Class
Class II
Regulation Number
882.1460
Review Panel
NE
Submission Type

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 GWN

  • K243709 — NeuroEars-Anna™ (August 25, 2025)
  • K242198 — ICS Dizcovery (1091) (February 14, 2025)
  • K242726 — Synapsys VHIT (January 3, 2025)
  • K223047 — NeuroSwift Pro (June 29, 2023)
  • K203082 — Insight Infrared Video Goggles (November 12, 2020)
  • K200534 — VisualEyes (August 12, 2020)
  • K192186 — I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Por (November 29, 2019)
  • K181771 — RightEye Vision System (September 28, 2018)
  • K182214 — DizzyDoctor System 1.0.0 (September 14, 2018)
  • K181025 — I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Por (July 24, 2018)