Cleared Traditional

K030180 - CRESCENT TINNITUS RETAINING SOUND GENERATOR (FDA 510(k) Clearance)

K030180 · Starkey Laboratories, Inc. · Ear, Nose, Throat device
Sep 2003
Decision
243d
Days
Class 2
Risk

K030180 is an FDA 510(k) clearance for the CRESCENT TINNITUS RETAINING SOUND GENERATOR. This device is classified as a Masker, Tinnitus (Class II - Special Controls, product code KLW).

Submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on September 17, 2003, 243 days after receiving the submission on January 17, 2003.

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

Submission Details

510(k) Number K030180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2003
Decision Date September 17, 2003
Days to Decision 243 days
Submission Type Traditional
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