Cleared Abbreviated

FONIX ,MODEL 8000

K093006 · Frye Electronics, Inc. · Ear, Nose, Throat
Dec 2009
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K093006 is an FDA 510(k) clearance for the FONIX ,MODEL 8000, a Calibrator, Hearing Aid / Earphone And Analysis Systems (Class II — Special Controls, product code ETW), submitted by Frye Electronics, Inc. (Tigard, US). The FDA issued a Cleared decision on December 30, 2009, 93 days after receiving the submission on September 28, 2009. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3310.

Submission Details

510(k) Number K093006 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2009
Decision Date December 30, 2009
Days to Decision 93 days
Submission Type Abbreviated
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code ETW — Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3310

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