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510(k) K935048

ARTISAN PROGRAMMER & HEARING AID by Telex Communications, Inc. — Product Code LRB

K935048 is an FDA 510(k) premarket notification submitted by Telex Communications, Inc. for the device "ARTISAN PROGRAMMER & HEARING AID". The FDA issued a decision of Substantially Equivalent on February 9, 1994. 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
February 9, 1994
Date Received
October 21, 1993
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)
  • 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 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)
  • K933037 — GOLD K AMP, ITE (August 2, 1993)
  • K933043 — SILVER PPP MODULE, ITE (August 2, 1993)
  • K933045 — SILVER RECHARGEABLE MODULE, ITE (August 2, 1993)
  • K933044 — SILVER LD MODULE, ITE (August 2, 1993)
  • K933040 — GOLD CD MODULE, ITE (August 2, 1993)
  • K933039 — GOLD L MODULE, ITE (August 2, 1993)

FDA data resources