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510(k) K974219

FACEPLATE ASSEMBLY by Finetone Hearing Instruments — Product Code LRB

K974219 is an FDA 510(k) premarket notification submitted by Finetone Hearing Instruments for the device "FACEPLATE ASSEMBLY". The FDA issued a decision of Substantially Equivalent on February 20, 1998. The device falls under product code LRB (Face Plate Hearing Aid), a Class I device regulated under 21 CFR 874.3300. Finetone Hearing Instruments has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1998
Date Received
November 10, 1997
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 Finetone Hearing Instruments

  • K955692 — FINETONE FSC, (February 2, 1996)
  • K945780 — FINETONE DISCEET CANAL (December 21, 1994)
  • K940164 — SUPER-SIL (June 29, 1994)
  • K830960 — CUSTOM IN-THE-EAR HEARING AID (June 30, 1983)

Other clearances for product code LRB

  • 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)
  • K933043 — SILVER PPP MODULE, ITE (August 2, 1993)
  • K933040 — GOLD CD MODULE, ITE (August 2, 1993)
  • K933045 — SILVER RECHARGEABLE MODULE, ITE (August 2, 1993)
  • K933044 — SILVER LD MODULE, ITE (August 2, 1993)
  • K933037 — GOLD K AMP, ITE (August 2, 1993)
  • K933039 — GOLD L MODULE, ITE (August 2, 1993)

FDA data resources