Cleared Traditional

K801905 - FONIX TYPE 5100 HEARING AID ANALYZER
(FDA 510(k) Clearance)

K801905 · Frye Electronics, Inc. · Ear, Nose, Throat

Aug 1980

Decision

16d

Days

Class 2

Risk

K801905 is an FDA 510(k) clearance for the FONIX TYPE 5100 HEARING AID ANALYZER, a Calibrator, Hearing Aid / Earphone And Analysis Systems (Class II — Special Controls, product code ETW), submitted by Frye Electronics, Inc. (Walker, US). The FDA issued a Cleared decision on August 27, 1980, 16 days after receiving the submission on August 11, 1980. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3310.

Submission Details

510(k) Number	K801905 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 1980
Decision Date	August 27, 1980
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—