Cleared Traditional

TYPE FA10 AUDIOMETER

K913221 · Frye Electronics, Inc. · Ear, Nose, Throat
Oct 1991
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K913221 is an FDA 510(k) clearance for the TYPE FA10 AUDIOMETER, a Audiometer (Class II — Special Controls, product code EWO), submitted by Frye Electronics, Inc. (Tigard, US). The FDA issued a Cleared decision on October 11, 1991, 84 days after receiving the submission on July 19, 1991. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K913221 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1991
Decision Date October 11, 1991
Days to Decision 84 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code EWO — Audiometer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1050