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510(k) K910901

FACEPLATE ITE HEARING AID MODEL 28A by Telex Communications, Inc. — Product Code LRB

K910901 is an FDA 510(k) premarket notification submitted by Telex Communications, Inc. for the device "FACEPLATE ITE HEARING AID MODEL 28A". The FDA issued a decision of Substantially Equivalent on May 30, 1991. The device falls under product code LRB (Face Plate Hearing Aid), a Class I device regulated under 21 CFR 874.3300. Telex Communications, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1991
Date Received
March 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Face Plate Hearing Aid
Device Class
Class I
Regulation Number
874.3300
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 LRB

  • K974219 — FACEPLATE ASSEMBLY (February 20, 1998)
  • K961593 — INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS (November 7, 1996)
  • K942722 — MODULE PROGRAM (September 6, 1994)
  • K942236 — AUDINA PREWIRES (FACEPLATE HEARING AID SERIES) (June 17, 1994)
  • K935048 — ARTISAN PROGRAMMER & HEARING AID (February 9, 1994)
  • K933040 — GOLD CD MODULE, ITE (August 2, 1993)
  • K933044 — SILVER LD MODULE, ITE (August 2, 1993)
  • K933039 — GOLD L MODULE, ITE (August 2, 1993)
  • K933037 — GOLD K AMP, ITE (August 2, 1993)
  • K933045 — SILVER RECHARGEABLE MODULE, ITE (August 2, 1993)

FDA data resources