Cleared Traditional

TYPE FP40 DIGITAL HEARING AID ANALYZER

K895383 · Frye Electronics, Inc. · Ear, Nose, Throat
Jan 1990
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K895383 is an FDA 510(k) clearance for the TYPE FP40 DIGITAL 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 January 22, 1990, 145 days after receiving the submission on August 30, 1989. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3310.

Submission Details

510(k) Number K895383 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 1989
Decision Date January 22, 1990
Days to Decision 145 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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