Cleared Traditional

TYPE 6400 REAL EAR HEARING AID ANALYZER

K872242 · Frye Electronics, Inc. · Ear, Nose, Throat
Jul 1987
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K872242 is an FDA 510(k) clearance for the TYPE 6400 REAL EAR 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 July 10, 1987, 29 days after receiving the submission on June 11, 1987. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3310.

Submission Details

510(k) Number K872242 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 1987
Decision Date July 10, 1987
Days to Decision 29 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code ETW — Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3310

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