Cleared Traditional

TYPE FP30 DIGITAL HEARING AID ANALYZER

K850918 · Frye Electronics, Inc. · Ear, Nose, Throat
May 1985
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K850918 is an FDA 510(k) clearance for the TYPE FP30 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 May 29, 1985, 85 days after receiving the submission on March 5, 1985. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3310.

Submission Details

510(k) Number K850918 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 1985
Decision Date May 29, 1985
Days to Decision 85 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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