Cleared Traditional

K980377 - FONIX FP35 HEARING AID ANALYZER
(FDA 510(k) Clearance)

K980377 · Frye Electronics, Inc. · Ear, Nose, Throat

Mar 1998

Decision

44d

Days

Class 2

Risk

K980377 is an FDA 510(k) clearance for the FONIX FP35 HEARING AID ANALYZER, 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 March 18, 1998, 44 days after receiving the submission on February 2, 1998. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3310.

Submission Details

510(k) Number	K980377 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 02, 1998
Decision Date	March 18, 1998
Days to Decision	44 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement