Cleared Traditional

GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)

K950730 · Phonic Ear, Inc. · Ear, Nose, Throat
Jun 1995
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K950730 is an FDA 510(k) clearance for the GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM), a Hearing Aid, Group And Auditory Trainer (Class II — Special Controls, product code EPF), submitted by Phonic Ear, Inc. (Petaluma, US). The FDA issued a Cleared decision on June 30, 1995, 134 days after receiving the submission on February 16, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3320.

Submission Details

510(k) Number K950730 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 1995
Decision Date June 30, 1995
Days to Decision 134 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code EPF — Hearing Aid, Group And Auditory Trainer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3320

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