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510(k) K942236

AUDINA PREWIRES (FACEPLATE HEARING AID SERIES) by Audina Hearing Instrument — Product Code LRB

K942236 is an FDA 510(k) premarket notification submitted by Audina Hearing Instrument for the device "AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)". The FDA issued a decision of Substantially Equivalent on June 17, 1994. 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
June 17, 1994
Date Received
May 9, 1994
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)
  • 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)
  • K897023 — OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID (March 16, 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)
  • K935048 — ARTISAN PROGRAMMER & HEARING AID (February 9, 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)
  • K933040 — GOLD CD MODULE, ITE (August 2, 1993)
  • K933044 — SILVER LD MODULE, ITE (August 2, 1993)
  • K933039 — GOLD L MODULE, ITE (August 2, 1993)

FDA data resources