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510(k) K933045

SILVER RECHARGEABLE MODULE, ITE by Electone, Inc. — Product Code LRB

K933045 is an FDA 510(k) premarket notification submitted by Electone, Inc. for the device "SILVER RECHARGEABLE MODULE, ITE". The FDA issued a decision of Substantially Equivalent on Aug 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
Aug 2, 1993
Date Received
Apr 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.

Other clearances for product code LRB

  • K974219 — FACEPLATE ASSEMBLY (Feb 20, 1998)
  • K961593 — INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS (Nov 7, 1996)
  • K942722 — MODULE PROGRAM (Sep 6, 1994)
  • K942236 — AUDINA PREWIRES (FACEPLATE HEARING AID SERIES) (Jun 17, 1994)
  • K935048 — ARTISAN PROGRAMMER & HEARING AID (Feb 9, 1994)
  • K933037 — GOLD K AMP, ITE (Aug 2, 1993)
  • K933043 — SILVER PPP MODULE, ITE (Aug 2, 1993)
  • K933040 — GOLD CD MODULE, ITE (Aug 2, 1993)
  • K933044 — SILVER LD MODULE, ITE (Aug 2, 1993)
  • K933039 — GOLD L MODULE, ITE (Aug 2, 1993)

FDA data resources