Cleared Traditional

K861571 - TYPE 6500 HEARING AID ANALYZER
(FDA 510(k) Clearance)

K861571 · Frye Electronics, Inc. · Ear, Nose, Throat

May 1986

Decision

32d

Days

Class 2

Risk

K861571 is an FDA 510(k) clearance for the TYPE 6500 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 May 30, 1986, 32 days after receiving the submission on April 28, 1986. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3310.

Submission Details

510(k) Number	K861571 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 1986
Decision Date	May 30, 1986
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—