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510(k) K933037

GOLD K AMP, ITE by Electone, Inc. — Product Code LRB

K933037 is an FDA 510(k) premarket notification submitted by Electone, Inc. for the device "GOLD K AMP, ITE". The FDA issued a decision of Substantially Equivalent on August 2, 1993. The device falls under product code LRB (Face Plate Hearing Aid), a Class I device regulated under 21 CFR 874.3300. Electone, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1993
Date Received
April 28, 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 Electone, Inc.

  • K973266 — Z DEQ-II (September 23, 1997)
  • K961084 — AM 400 (April 18, 1996)
  • K955702 — SONATA U-01 (February 22, 1996)
  • K953047 — Z20 (August 22, 1995)
  • K953050 — Z33 (August 22, 1995)
  • K953048 — Z22 (August 15, 1995)
  • K953054 — AM 260 OHM (August 15, 1995)
  • K953049 — Z24 (August 15, 1995)
  • K953052 — AM 260 K-AMP (August 15, 1995)
  • K953051 — Z35 (August 15, 1995)

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)
  • K933040 — GOLD CD MODULE, 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)
  • K933039 — GOLD L MODULE, ITE (August 2, 1993)

FDA data resources