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510(k) K863156

TECA/MEDELEC AUDIOSTAR by Teca, Inc. — Product Code GWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1987
Date Received
August 18, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Auditory, Evoked Response
Device Class
Class II
Regulation Number
882.1900
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)

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  • K220139 — QScreen (August 3, 2022)
  • K211147 — ALGO 7i (October 14, 2021)
  • K193033 — GSI Audera Pro (April 24, 2020)
  • K163326 — SmartEP (September 29, 2017)
  • K162037 — Eclipse with VEMP (March 23, 2017)
  • K143670 — ICS CHARTR EP 200 WITH VEMP (October 23, 2015)
  • K141446 — ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO H (August 22, 2014)
  • K132957 — MADSEN ACCUSCREEN TYPE 1077 (February 27, 2014)