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510(k) K897023

OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID by Audina Hearing Instrument — Product Code LRB

K897023 is an FDA 510(k) premarket notification submitted by Audina Hearing Instrument for the device "OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID". The FDA issued a decision of Substantially Equivalent on March 16, 1990. The device falls under product code LRB (Face Plate Hearing Aid), a Class I device regulated under 21 CFR 874.3300. Audina Hearing Instrument has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1990
Date Received
December 19, 1989
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 Audina Hearing Instrument

  • K964816 — AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR (January 17, 1997)
  • K953960 — HEARING AID (ALL-IN-THE-EAR) (September 12, 1995)
  • K942236 — AUDINA PREWIRES (FACEPLATE HEARING AID SERIES) (June 17, 1994)
  • K936190 — BEHIND THE EAR HEARING AID (April 4, 1994)
  • K930271 — BEHIND-THE-EAR HEARING AID (March 18, 1993)
  • K897024 — MODEL AUDINA ITE HEATING AID (April 18, 1990)
  • K820833 — AUDICRAFT VIP HEARING AID (April 9, 1982)

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

FDA data resources