GOLD AF MODULE, ITE— 510(k) K933038

Substantially Equivalent

Electone, Inc.

FDA 510(k) clearance K933038 for GOLD AF MODULE, ITE, Substantially Equivalent on 1993-08-02. Applicant: Electone, Inc.. Device class: 1.

Clearance details

Applicant: Electone, Inc.
Product code: Code LRB
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1993-04-28
Decision date: 1993-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longwood, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LRB

K974219 — FACEPLATE ASSEMBLY1998-02-20
K961593 — INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS1996-11-07
K942722 — MODULE PROGRAM1994-09-06
K942236 — AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)1994-06-17
K935048 — ARTISAN PROGRAMMER & HEARING AID1994-02-09

More clearances from Electone, Inc.

Data sourced from openFDA. This site is unofficial and independent of the FDA.