Cleared Traditional

DIGITAL AUDIOMETER/HEARING AID 3100

K833883 · Frye Electronics, Inc. · Ear, Nose, Throat

Feb 1984

Decision

104d

Days

Class 2

Risk

About This 510(k) Submission

K833883 is an FDA 510(k) clearance for the DIGITAL AUDIOMETER/HEARING AID 3100, a Audiometer (Class II — Special Controls, product code EWO), submitted by Frye Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984, 104 days after receiving the submission on November 9, 1983. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number	K833883 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 09, 1983
Decision Date	February 21, 1984
Days to Decision	104 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—