Cleared Traditional

FM RECEIVER - AUDITORY TRAINER

K974287 · Phonic Ear, Inc. · Ear, Nose, Throat
Feb 1998
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K974287 is an FDA 510(k) clearance for the FM RECEIVER - AUDITORY TRAINER, 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 February 10, 1998, 88 days after receiving the submission on November 14, 1997. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3320.

Submission Details

510(k) Number K974287 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 1997
Decision Date February 10, 1998
Days to Decision 88 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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