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510(k) K915383

TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER by Telex Communications, Inc. — Product Code EPF

K915383 is an FDA 510(k) premarket notification submitted by Telex Communications, Inc. for the device "TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER". The FDA issued a decision of Substantially Equivalent on January 17, 1992. The device falls under product code EPF (Hearing Aid, Group And Auditory Trainer), a Class II device regulated under 21 CFR 874.3320. Telex Communications, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1992
Date Received
November 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Group And Auditory Trainer
Device Class
Class II
Regulation Number
874.3320
Review Panel
EN
Submission Type

Other clearances by Telex Communications, Inc.

  • K984243 — TELEX TINNITUS-COMPANION (January 21, 1999)
  • 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)

Other clearances for product code EPF

  • K133352 — HYPERSOUND AUDIO SYSTEM (HSS) (February 12, 2014)
  • K982683 — TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION (October 6, 1998)
  • K974658 — INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIV (February 25, 1998)
  • K974287 — FM RECEIVER - AUDITORY TRAINER (February 10, 1998)
  • K970687 — WILLIAMS SOUND, PERSONAL FM, HEARING HELPER (May 2, 1997)
  • K970665 — WILLIAMS SOUND, PERSONAL FM, HEARING HELPER (May 2, 1997)
  • K960567 — HF MEGA EAR (October 16, 1996)
  • K950730 — GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM) (June 30, 1995)
  • K941768 — PHONAK MICROVOX RESONAL FM SYSTEM (June 24, 1994)
  • K940313 — PHONIC EAR (March 22, 1994)

FDA data resources