Cleared Traditional

PE 400IR, PE 400T, PE 400E

K923234 · Phonic Ear, Inc. · Ear, Nose, Throat
Sep 1992
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K923234 is an FDA 510(k) clearance for the PE 400IR, PE 400T, PE 400E, 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 September 29, 1992, 90 days after receiving the submission on July 1, 1992. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3320.

Submission Details

510(k) Number K923234 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1992
Decision Date September 29, 1992
Days to Decision 90 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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