Cleared Special

K061459 - TRANQUIL TRI-BTE
(FDA 510(k) Clearance)

K061459 · General Hearing Instruments, Inc. · Ear, Nose, Throat
Jun 2006
Decision
35d
Days
Class 2
Risk

K061459 is an FDA 510(k) clearance for the TRANQUIL TRI-BTE. This device is classified as a Masker, Tinnitus (Class II — Special Controls, product code KLW).

Submitted by General Hearing Instruments, Inc. (New Orleans, US). The FDA issued a Cleared decision on June 30, 2006, 35 days after receiving the submission on May 26, 2006.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3400.

Submission Details

510(k) Number K061459 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 2006
Decision Date June 30, 2006
Days to Decision 35 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code KLW — Masker, Tinnitus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3400