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510(k) K961593

INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS by Segi Hearing Aid Co. — Product Code LRB

K961593 is an FDA 510(k) premarket notification submitted by Segi Hearing Aid Co. for the device "INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS". The FDA issued a decision of Substantially Equivalent on November 7, 1996. The device falls under product code LRB (Face Plate Hearing Aid), a Class I device regulated under 21 CFR 874.3300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1996
Date Received
April 24, 1996
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 for product code LRB

  • K974219 — FACEPLATE ASSEMBLY (February 20, 1998)
  • 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)
  • K933043 — SILVER PPP MODULE, ITE (August 2, 1993)

FDA data resources