Home / 510(k) Clearances / K984243

510(k) K984243

TELEX TINNITUS-COMPANION by Telex Communications, Inc. — Product Code KLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1999
Date Received
November 27, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Masker, Tinnitus
Device Class
Class II
Regulation Number
874.3400
Review Panel
EN
Submission Type

Other clearances by Telex Communications, Inc.

  • K982683 — TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION (October 6, 1998)
  • K964639 — TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II (January 21, 1997)
  • K963915 — TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION (November 8, 1996)
  • K961143 — TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40 (May 7, 1996)
  • K954579 — TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION (December 8, 1995)
  • K943961 — THE MODEL ACAPPELLA IN THE EAR HEARING AID (May 15, 1995)
  • K935048 — ARTISAN PROGRAMMER & HEARING AID (February 9, 1994)
  • K935366 — BINAURAL HEARING AID (January 13, 1994)
  • K933579 — MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AID (August 23, 1993)
  • K933095 — 351-AGCO BEHIND-THE-EAR HEARING AID (July 26, 1993)

Other clearances for product code KLW

  • K233435 — Peace N Quiet (0.7.0) (February 27, 2024)
  • K223694 — Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) (June 30, 2023)
  • K221168 — Tinnitogram Signal Generator (February 1, 2023)
  • K221125 — SilentCloud (January 4, 2023)
  • K201370 — Multiflex Tinnitus Technology (June 19, 2020)
  • K193303 — Tinnitus Sound Generator Module (February 20, 2020)
  • K180495 — Tinnitus Sound Generator Module (November 30, 2018)
  • K181586 — Tinnitus Sound Generator Module (July 13, 2018)
  • K171243 — audifon Tinnitus-Module (October 19, 2017)
  • K163094 — TinniLogic Mobile Tinnitus Management Device (May 17, 2017)