Home / 510(k) Clearances / K903731

510(k) K903731

SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME by Teca, Inc. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1991
Date Received
August 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Evoked Response
Device Class
Class II
Regulation Number
882.1870
Review Panel
NE
Submission Type

Other clearances by Teca, Inc.

  • K962283 — EEG ELECTRODES (December 16, 1996)
  • 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)
  • K862906 — TECA/MEDELEC AS-10 SENSOR (February 4, 1987)

Other clearances for product code GWF

  • K252842 — SafeOp 3: Neural Informatix System (January 11, 2026)
  • K243982 — Nicolet EDX (January 22, 2025)
  • K243495 — Natus Ultrapro S100 (982A0594) (December 12, 2024)
  • K242345 — Delphi Stimulator (November 5, 2024)
  • K234092 — SafeOp 3: Neural Informatix Systeem (April 19, 2024)
  • K234080 — MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) (March 25, 2024)
  • K233292 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (October 27, 2023)
  • K230415 — Cadwell Guardian (August 17, 2023)
  • K213849 — SafeOp 2: Neural Informatix System (March 9, 2022)
  • K212166 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (January 7, 2022)